Recall Z-1013-2013 ยท LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
| Date | Mar 27, 2013 (initiated Feb 6, 2013) |
| Status | Terminated |
| Reason | The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. |
| Root cause | Error in labeling |
| Action | bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice. |
| Quantity | 4/20-card cartons |
| Distribution | Distributed only in HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.