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bioMerieux, Inc. recalls VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Recalled December 26, 2018 · FDA recall Z-0639-2019 · bioMerieux
Hazard
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. · FDA Class II
Units
five (5) VITEK¿ 2 Systems Software version 9.01
Sold at
Nationwide distribution to CO, IL, MO, TX.
Description
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.
Product
VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Manufacturer(s)
bioMerieux, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →