Recall Z-2050-2011 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'Etoile France. The cards 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 gram-ne
| Date | Apr 27, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| Reason | 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 sent an Urgent Product Correction Notice (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786," letter dated March 30, 2011, via Fed EX on April 4, 2011. to all affected customers. 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/Tazobactam (TZP2). The new cards will begin shipping by July 16, 2 |
| Quantity | 3,000 boxes as of 3/31/11 |
| Distribution | There was no U.S. distribution as the cards were for export only to Canada and Sweden. |
| 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 |