FDA-Device2018-12-26Class II

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

bioMerieux, Inc.
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.

Sold states
Nationwide distribution to CO, IL, MO, TX.
Affected count
five (5) VITEK¿ 2 Systems Software version 9.01
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VITEK¿ 2 Systems Software Version 9.01 Update Kit.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0639-2019

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