Company: BioMerieux SA
Date of Enforcement Report: 10/20/2021
Class II
PRODUCT
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Recall Number: Z-0084-2022
REASON
Under certain conditions, there is a risk for a false negative result.
RECALLING FIRM/MANUFACTURER
BioMerieux SA on 9/2/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
542 units
DISTRIBUTION
U.S. Nationwide and International