Device product
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.
Z-1742-2020
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 85209
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1698 cartons (15,940 cards)
- Official record key
device-enforcement:Z-1742-2020
Official wording
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). .
Code information: VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
Distribution pattern: No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Derived failure modes
-
Unknown
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). .