Recall – Microbial identification system software error

Company: bioMerieux, Inc.
Date of Enforcement Report: 12/19/2018
Class II

PRODUCT

VITEK 2 Systems Software Version 9.01 Update Kit.

Recall Number: Z-0639-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

bioMerieux, Inc., Durham, NC on 11/13/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
(5) VITEK 2 Systems Software version 9.01

DISTRIBUTION
U.S. Nationwide

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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