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