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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall addresses a risk for false negative results under certain conditions. The software failure could lead to missed diagnoses, representing significant potential for patient harm. However, no illnesses or injuries have been reported. This fits the 'High' severity category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioMerieux SA is recalling MYLA diagnostic system software versions 4.7, 4.7.1, 4.8, 4.8.1, and 4.8.2, which are part of the VIRTUO diagnostic system. Approximately 542 units containing the affected software have been distributed.
Under certain conditions, the software may produce false negative results. This means the system could fail to detect a positive sample, potentially leading to missed diagnoses.
The affected software has been distributed worldwide, including throughout the United States and internationally to approximately 30 countries: Austria, Australia, Belgium, Canada, Switzerland, Chile, Colombia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, the Netherlands, Norway, Poland, Portugal, Sweden, Singapore, and South Africa.
Users of the affected VIRTUO system software should contact BioMerieux SA regarding this recall to obtain updated software versions and information about addressing this issue.
The recalled product
- Product
- MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
- Manufacturer
- BioMerieux SA
- Affected units
- 542
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- MYLA Software version 4.7
- 4.7.1
- 4.8
- 4.8.1 and 4.8.2
Distribution
Distributed nationwide across the United States.
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