bioMerieux VITEK 2 and MYLA diagnostic software recall for anomalies
bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for medical device software with reported anomalies. No illnesses, injuries, or deaths have been reported, and the potential impact is described as theoretical. Per the severity rubric, recalls explicitly lacking reported harm with theoretical risk are classified as Moderate.
Plain-English summary
bioMerieux, Inc. is recalling specific versions of VITEK 2 and MYLA software due to seven reported software anomalies that may affect use of the devices. These are diagnostic laboratory systems used for microorganism identification and analysis.
The affected VITEK 2 software versions are 8.01, 8.02 (veterinary use only), 9.01, 9.02, and 9.03. The affected MYLA software versions are V4.8 and V4.9. The recalled software was distributed internationally to Estonia, Bahrain, Pakistan, the United Kingdom, Singapore, Saudi Arabia, Thailand, and Vietnam.
The recalled product
- Product
- VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
- Manufacturer
- bioMerieux, Inc.
- Hazard
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 (11)
- VITEK 2 Software Versions 8.01
- 8.02 (veterinary only)
- 9.01
- 9.02
- 9.03 / MYLA Software Versions V4.8
- V4.9 UDI/GTIN: 03573026553968
- 03573026619060
- 03573026609399
- 03573026613914
- 03573026619244
- 03573026621568
Distribution
Distribution scope not specified by the agency.
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