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Biomerieux Inc recalls Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek
Recalled May 20, 2015 · FDA recall Z-1602-2015 · Biomerieux
Hazard
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 · FDA Class II
Units
43,535/20-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-YS07 REF 414 967, 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 →