Biomerieux Inc recalls Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek

Recalled May 20, 2015 · FDA recall Z-1603-2015 · Biomerieux

Hazard

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. · FDA Class II

Units

1604/20-card cartons

Sold at

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

Description

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.

Product

Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

Manufacturer(s)

Biomerieux Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →