bioMerieux Recalls VIDAS Testosterone Assay Due to Overestimated Results
bioMerieux is recalling 742 units of VIDAS Testosterone assays because they may produce falsely overestimated results.
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, but the source text does not report any hospitalizations, injuries, or deaths, only inaccurate test results. This aligns with the Moderate severity criteria for low-risk issues or voluntary precautionary recalls without reported harm.
Plain-English summary
bioMerieux, Inc. is recalling 742 units of VIDAS Testosterone, Ref 30418. The recall involves Lots 1004878310 and 1005001080. The product was distributed to locations in the United States and internationally, including specific states and countries such as France, Sweden, and Ukraine.
The recall was initiated after complaints were received from customers who observed falsely overestimated results or external quality control results higher than expected when performing tests with the VIDAS Testosterone assay. This issue may affect the accuracy of testosterone measurements in clinical settings.
Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact bioMerieux, Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- VIDAS Testosterone, Ref 30418
- Manufacturer
- bioMerieux, Inc.
- Hazard
- Affected units
- 742
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 (1)
- Lots 1004878310 & 1005001080
Distribution
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