Recall Z-0084-2022— BioMerieux SA

Name: FDA recall Z-0084-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-02

Class II · Terminated

Class II FDA medical device recall by BioMerieux SA, initiated 2021-09-02, terminated 2026-03-09. FDA's recall record names no specific 510(k) clearance for this event. Product: MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System. Reason: Under certain conditions, there is a risk for a false negative result..

Recalling firm: BioMerieux SA
Classification: Class II
Status: Terminated
Initiated: 2021-09-02
Terminated: 2026-03-09
Firm location: La Balme les Grottes, N/A, France

Product description

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

Reason for recall

Under certain conditions, there is a risk for a false negative result.

Data sourced from openFDA. This site is unofficial and independent of the FDA.