BioMerieux Recalls VIDAS 3 Software Version 1.1.4 Due to Anomalies
BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 in the U.S. because anomalies identified during the development of version 1.2 were found to be present in the current field version.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths. The hazard is described as 'anomalies' without specific details of harm, fitting the criteria for a moderate severity recall involving a potential defect without reported adverse health consequences.
Plain-English summary
BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 distributed in the United States. The recall is associated with reference number #412590 and software version 1.1.4.
The recall was initiated because anomalies were identified during the development of VIDAS 3 software version 1.2. These anomalies were observed to be already present in the current software version, VIDAS 3 version 1.1.4, which is available in the field. The source text does not specify the nature of the anomalies or any reported adverse events, injuries, or illnesses.
Users of the affected software should contact BioMerieux SA for further instructions regarding the recall and potential software updates or replacements.
The recalled product
- Product
- VIDAS 3 software v. 1.1.4
- Manufacturer
- BioMerieux SA
- Hazard
- Affected units
- 1,161
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 (2)
- REF: #412590
- Lot: Software version 1.1.4
Distribution
Distribution scope not specified by the agency.
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