Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Russia.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: biomerieux vitek 2 gram positive antimicrobial susceptibility testing (ast) cards
the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive cefoxitin screen and vitek 2 gram positive ast for oxacillin [lot numbers: all lots of gram positive ast cards with oxacillin and cefoxitin tests; manufacturing and distribution dates: 8 february 2017 to present], manufactured by biomerieux.
the manufacturer is recalling the affected products because of false negative or false susceptible results for some strains of methicillin-resistant staphylococcus aureus (mrsa). it is continuing to investigate the issue to determine the root cause of the failure and the prevalence of the strains that are subject to erroneous results.
according to the manufacturer, missed diagnosis and inappropriate treatment of mrsa could cause severe health consequences, including lack of treatment for a mrsa infection, and death.
the manufacturer recommends that labs confirm potential mrsa upon activation of the software bioart rule. the mrsa safety alert letter is issued directing labs to:
implement a custom vitek 2 system software bioart rule to aid in mitigating potential non-detection of mrsa when testing oxacillin (ox) and cefoxitin screen (oxsf) on vitek 2,
enable the advanced expert system on the vitek 2 systems software to ensure that the appropriate forcing rules are applied to test results regardless of the parameter set in use, and
use the existing strain submission system to send isolates of suspect strains of mrsa to the manufacturer for additional testing.
for details, please refer to the following fda website:
https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm618135.Htm
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 24 august 2018.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ortho-clinical diagnostics (ocd) received complaints of results for patient and proficiency samples were elevated in some instances. proficiency sample results when using vitros ca 19-9 kit lot 1320, compared to previous kit lots used and analysed (ocd internal testing), found an overall average positive bias of approximately +30% for samples within the normal range (<=37 u/ml) and +17% for samples above the normal range (>37 u/ml).
Acción
Laboratories are being advised to immediately discontinue using and discard all remaining inventory of VITROS CA19-9 Calibrators and Reagent Packs, Lot 1320.
Review previously reported results using VITROS CA 19-9 Reagent Packs, Lot 1320 and discuss any concerns regarding previously reported results with your Laboratory Medical Director or the requesting physician to determine the appropriate course of action.
Ortho-Clinical Diagnostics (OCD) will provide credits/replace stock of any product affected by this recall. This action has been closed-out on 12/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Under specific conditions, vitek 2 60/xl and vitek 2 compact pc systems connected to a laboratory information system have the potential to link a test result to an incorrect patient record. the four conditions required to potentially cause an occurrence of this issue are:- patient demographics option is enabled- patient demographics are not associated with the isolate- user does not resolve qualified isolates- laboratory re-uses lab ids (accession numbers) prior to qualified isolates being resolved.
Acción
Biomerieux is updating the instructions for use (IFU), addendum to the software user manual, to include appropriate instructions for resolution of Qualified isolates as a short term action. Biomerieux is implementing a software solution to reduce the likelihood of occurrence of this issue in the next software update, version 7.01 targeted for launch in November 2013.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications
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