Recall Z-1403-2015 ยท LTW Susceptibility Test Cards, Antimicrobial
Biomerieux Inc
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
| Date | Apr 8, 2015 (initiated Feb 25, 2015) |
| Status | Terminated |
| Reason | The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. |
| Root cause | Employee error |
| Action | Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to de |
| Quantity | 1505 cartons |
| Distribution | Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.