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.
Falsely lowered imipenem mics may result, leading to major errors in results.
Acción
Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
Falsely lowered imipenem mics may result, leading to major errors in results.
Acción
Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance.
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
Antinuclear Antibody Immunological Test System - Product Code LJM
Causa
The calibrator value is printed incorrectly on the sm elisa test system, lot # 08041819. the calibrator value (cv) printed on the label is 102; the correct cv should read 266.
Acción
Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies - Product Code NWY
Causa
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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
SimulFluor Flu A/Flu B Immunofluorescence Assay - Product Code GNW
Causa
Certain lots of simulfluor flu a / flu b reagent may cross-react with respiratory synctial virus. the continued use of simulfluor flu a / flu b reagent catalog #5250 may lead to a potential misdiagnosis of influenza b.
Acción
Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail.
Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.
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
SimulFluor Flu A/Flu B Immunofluorescence Assay - Product Code GNW
Causa
Certain lots of simulfluor flu a / flu b reagent may cross-react with respiratory synctial virus. the continued use of simulfluor flu a / flu b reagent catalog #5250 may lead to a potential misdiagnosis of influenza b.
Acción
Millipore is performing a voluntary recall by notifying customers and distributors by telephone on November 24, 2008. In addition, an Urgent: Medical Device Recall notification letter with the same date was sent via certified mail.
Customers were advised to examine their stock immediately and discontinue the use of the specified lots. Customers were instructed to complete the enclosed Effective Check Survey confirming disposal of defective lots and return this form to Millipore's Regulatory Department. Customer service is to be contacted at 1-800-437-7500 for replacement product. Millipore Corporation will issue credit or replace the recalled lots that customers currently have in inventory.
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
ANA Flurescent Test System/Colorzyme Test System - Product Code DHN
Causa
Samples can occasionally run out of the wells and cross contaminate adjacent wells.
Acción
The firm notified customers via a "Notice of Market Withdrawal" letter, e-mail and telephone. The letter described the problem and instructed customers to removed affected product from their inventory, complete the attached form and return it via fax to Immuno Concepts, Inc. at 916-363-2843. The firm will issue replacements as requested. Direct questions to Immuno Concepts, Inc. at 916-363-2649.
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
Extractable antinuclear antibody, antigen and control - Product Code LLL
Causa
In certain patient samples, it is difficult to properly discriminate between anti-sm/rmp positive samples and samples that are only anti-sm positive.
Acción
The firm has issued telephone calls, e-mails and notification letters to its consignees.
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
Epstein-Barr Virus, Other - Product Code LSE
Causa
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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
Helicobacter Pylori - Product Code LYR
Causa
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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
Helicobacter Pylori - Product Code LYR
Causa
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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.
The recall has been initiated due to the "for export only" labeling found on some calbiotech, inc. elisa kits. although there is no potential health hazard related to this recall, calbiotech is fully committed to compliance with all state and federal regulations.
Acción
Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Please return any product you currently have in stock which is subject to this recall and noted on the attached list. Any product you return will be replaced free of charge. Please use our FedEx account: 2284-6203-9 and send any packages via "FedEx Saver" service.
This recall should be carried out to the wholesale level in order to comply with Federal regulations.
Please complete and return the enclosed response form as soon as possible. If you have any questions, please contact David Barka at 619-660-6162.
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
Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
Causa
These lots may exhibit false positive reactions with strains of staphylococcus epidermidis that may result in the mis-identification of staphylococcus aureus.
Acción
Consignees were notified of the recall via letter dated 11/20/08 explaining the reason for recall and requesting any remaining units from the lots be discarded. A Product Inventory Checklist was enclosed to report the amount of product remaining in their inventory. Any non-responding consignees were contacted via telephone during the period of 12/30/08 to 1/11/09 to ensure the effectiveness of the recall.
When the recall was expanded to include additional lots, the recalling firm issued an Important Medical Device Customer Recall Notice letters dated 3/16/09 again explaining the reason for recall. The letter also asked consignees to review their inventories for the product lots indicated and requested that remaining units from the lots be discarded. This letter also had a Product Inventory Checklist enclosed for completion.
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.
Bd diagnostics geneohm (bddg) has determined that the cepheid smartcycler reaction tubes packaged in the bd geneohm mrsa test kits identified above may be defective.
Acción
BD Diagnostics GeneOhm began contacting consignees by phone November 17, 2008 followed by a letter dated November 21, 2008 instructing discontinued use of the affected lots. Consignees were also asked to complete and return the enclosed Field Action Verification form.
To arrange for product replacement or for further information, contact BD Diagnostics Technical Service at 1-888-436-3646 extension 2.
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.
The plate labeling is incorrect, but the outer box labeling is correct.
Acción
The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.
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.
The products may give false positive results with some non-staphylococcus aureus strains.
Acción
Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail.
For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.
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.
The products may give false positive results with some non-staphylococcus aureus strains.
Acción
Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail.
For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.