Company: BioMerieux SA
Date of Enforcement Report: 8/18/2021
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
Software anomaly – Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
BioMerieux SA on 6/22/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE