U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Acción
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
in vitro diagnostic - Product Code DAK
Causa
The recall was initiated after the binding site notified inova diagnostics, inc. that the affected bindazyme human c1q binding circulating immune complex eia kits may contain an elisa plate labeled as "tissue transglutaminase coated wells" instead of "c1q coated wells".
Acción
Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009.
The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
CMV IgG - Product Code LFX
Causa
The recall was initiated because siemens healthcare diagnostics has identified there is the potential for patient results to be biased low (-0.3 sample to cutoff [s/co] ratio units) due to incompatibility of the toxoplasma igm kits with this particular lot of igg/igm sample diluent. all available lots of the immulite 2000/2500 toxoplasma igm kits (l2ktm/l5ktm) are incompatible with diluent lot 150.
Acción
The customer notification was initiated on 10/22/2009 with the firm forwarding an Urgent Field Safety notice with attached Field Correction Effectiveness Check form to the affected consignees informing them of the issue and the products affected. The consignees were informed that Siemens is initiating the Field Correction (FC) to prevent IMMULITE 2000/2500 Toxoplasma IgM from being run with Diluent lot 150.
The consignees were instructed in the interim, until replacement kit lots of RUB IgG and CMV IgG are received, your laboratory can continue using Rubella IgG, CMV IgG, or Toxoplasma IgM as long as Diluent Lot 150 is not loaded on the analyzer when running Toxoplasma IgM. Diluent Lot
150 can be used with RUB IgG and CMV IgG.
Once the replacements lots are received, any unopened kit lots listed in the above table MUST BE RETURNED to Siemens per instructions that will accompany a separate Fed Ex Call Tag that will explain the proper return of the affected product.
The consignees were also instructed to complete the attached Field Correction Effectiveness Check form and fax to the firm's technical solutions center.
Additional questions should be directed to the firm at 973-927-2828.