bioMerieux, Inc. recalls VITEK¿ 2 Systems Software Version 9.01 Update Kit.

Recall date

November 13, 2018

Source

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

Recall number

Z-0639-2019

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

Nationwide distribution to CO, IL, MO, TX.

Why it was recalled

The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.

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 Systems Software Version 9.01 Update Kit.