Recall Z-0277-2011 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N178, REF 410 393, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France. Cards that are intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic
| Date | Nov 11, 2010 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptibility and false resistance results for E. coli; and the same drug is providing false susceptibility results for Klebsiella. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | Product not distributed as of 9/10/10 |
| Distribution | Worldwide Distribution: USA (all states), and the countries of: SUBSIDIARIES - Argentina, Canada, Switzerland, Chile, Colombia, Germany, Spain, Great Britain, Hong Kong, Japan, Korea, Mexico, Poland, Brazil, Sweden, Singapore, and Thailand. DISTRIBUTORS - Dutch Antilles, Australia, Bermuda, Urugu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080107 | VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM bioMerieux, Inc., Feb 28, 2008 |