Recall Z-1137-2019 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
bioMerieux, Inc.
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
| Date | Mar 15, 2019 |
| Status | Terminated |
| Reason | Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits. |
| Root cause | Software change control |
| Action | On 03/15/2019, the firm, BioMerieux sent notifications to all their consignees with the following instructions: "Please take the following actions at this time: Confirm this letter has been distributed to, and reviewed by, all appropriate personnel within your organization. Apply the VITEK 2 Systems bioART rule criteria as previously mentioned (i.e., using the criteria listed below for ESBL / E. coli isolates). Refer to Appendix A for detailed instructions. o If the card is AST-NXXX (where XXX indicates the card type designation, 254 / 330 / 371) o The organism is Escherichia coli o And the |
| Quantity | 10784 cartons |
| Distribution | Internationally to: United Kingdom, Latvia, Poland, Ukraine, Germany, and Scotland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.