Recall Z-0211-2011 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N104, REF 22 261, 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.
| Date | Nov 11, 2010 (initiated Sep 16, 2010) |
| Status | Terminated |
| Reason | 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. |
| 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 | 24,749 boxes as of 3/8/11 |
| 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 |