bioMerieux product recalled over mold contamination

Recall date

February 5, 2020

Source

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

Official notice title

bioMerieux, Inc. recalls VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reag…

Recall number

Z-1534-2020

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

International distribution in the countries of Germany and the Netherlands.

Why it was recalled

The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.

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 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.