Biomerieux Inc recalls The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as…

Recall date

March 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1742-2020

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium

Why it was recalled

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). .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.