Recall Z-2817-2018 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
bioMerieux, Inc.
bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic syst
| Date | Aug 30, 2018 (initiated Jan 26, 2018) |
| Status | Terminated |
| Reason | Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product. |
| Root cause | Under Investigation by firm |
| Action | bioMerieux sent an Urgent Product Correction Notice letter to their French customers on January 26, 2018. Customer letters in the Americas were sent August 21, 2018. The letters identified the affected product, problem, and actions to be taken. Customers should follow steps outlined in the letter and contact bioMerieux for any additional questions regarding these corrective actions. Note: the actions do not include removal of the product. For any questions or concerns, contact your local bioMerieux representative. |
| Quantity | 13,961,320 US |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar, Nicaragua, Peru, Philippines, Paraguay, Singapore, Thailand, El |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053097 | VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN bioMerieux, Inc., Dec 14, 2005 |