FDAFDA · Food and drugs·Recall number Z-2225-2021
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.
Published August 18, 2021 · Recall initiated: June 22, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioMerieux SA
- Distributor
- Distribution in the U.S. was nationwide. There was also military and government distribution.
- Lot
- MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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