medical Class II Updated 2020-04-29

Biomerieux Inc recalls The VITEK 2 Gram-positive Susceptibility Card is intended fo

Recalled 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.


Hazard / Issue

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). .

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
View official government recall

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