Recall Z-0847-2019 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
bioMerieux, Inc.
VITEK 2 AST-N351 Test Kit
| Date | Dec 13, 2018 |
| Status | Terminated |
| Reason | False Positive ESBL Phenotype |
| Root cause | Software Design Change |
| Action | On 12/13/2018 bioMerieux submitted a communication to their distributor in the UK stating the following: Our Ref: 4191-1 FSCA Dear Valued bioMrieux Customer, Our records indicate that your laboratory uses the VITEK 2 System in conjunction with the VITEK 2 AST-N351 test kit. Description of Issue: bioMrieux has received reports from VITEK 2 customers that an unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype has been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N351 (ref. 421257) test kit. When an ESBL phenotype is proposed by VITEK 2 Systems So |
| Quantity | 30,292 cartons (20 cards per carton) |
| Distribution | UK and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.