Recall Z-1742-2020 ยท N/A
Biomerieux Inc
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
| Date | Mar 11, 2020 |
| Status | Open, Classified |
| Reason | There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). . |
| Root cause | Under Investigation by firm |
| Action | On March, 11, 2020 a notification letter was issued to the impacted subsidiaries which included a Customer Letter to be translated into local language. The customer letter instructs the customer to stop the use of the impacted AST-P652 lot, to complete the attached Acknowledgement Form, and return any affected unused product to their local bioMrieux representative as soon as possible. |
| Quantity | 1698 cartons (15,940 cards) |
| Distribution | No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053097 | VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN bioMerieux, Inc., Dec 14, 2005 |