Biomerieux Recalls VIDAS CMV IgM Tests Due to Calibration Issues
Biomerieux is recalling VIDAS CMV IgM test kits due to reported calibration issues. The recall affects 18,705 kits distributed nationwide and internationally.
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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Biomerieux Inc is recalling 18,705 units of VIDAS CMV IgM test kits (reference 30205 and 30205-01). The recall was initiated after the company received complaints regarding calibration issues observed on several lots of the product.
The affected lots include 1008143230, 1008182270, 1008363970, 1008433580, 1008143260, and 1008363980, with expiration dates ranging from May 2021 to October 2021. These kits were distributed to facilities in numerous U.S. states and internationally to countries across the Americas, Europe, Asia, Africa, and the Middle East.
This is a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible health consequences. Users should stop using the affected kits and contact Biomerieux for instructions on return or replacement.
The recalled product
- Product
- VIDAS¿ CMV IgM 30 Tests
- Manufacturer
- Biomerieux Inc
- Hazard
- Affected units
- 18,705
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 (5)
- ref 30205
- lot numbers 1008143230 (exp. date: 04 MAY 2021)
- 1008182270 (exp. date: 26 MAY 2021)
- 1008363970 (exp. date: 01 SEP 2021)
- 1008433580 (exp. date: 15 OCT 2021) US ref 30205-01
Distribution
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