MYLA Diagnostic System Software Versions Recalled for Risk of False Negatives
BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.
- Product
- MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
- Category
- Medical Device
- Distribution
- Distributed nationwide