Biomerieux product recalled over mold contamination

Recall date

March 27, 2015

Source

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

Official notice title

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

Recall number

Z-1603-2015

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

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

Why it was recalled

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

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

What was recalled

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.