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

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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