Company: BioMerieux SA
Date of Enforcement Report: 8/18/2021
Class II
PRODUCT
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
Recall Number: Z-2225-2021
REASON
Software anomaly – Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
RECALLING FIRM/MANUFACTURER
BioMerieux SA on 6/22/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
248 systems
DISTRIBUTION
U.S. Nationwide