Recall Z-2225-2021— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2021-06-22, terminated 2023-02-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-22
- Terminated
- 2023-02-06
- Firm location
- Marcy L'Etoile, N/A, France
Product description
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.
Reason for recall
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Data sourced from openFDA. This site is unofficial and independent of the FDA.