BioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues
BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.
What this means for you
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 illnesses. The hazard is a technical calibration error rather than a direct physical safety risk, fitting the criteria for a moderate severity score.
Plain-English summary
BioMerieux SA is recalling VIDAS FSH, Ref 30407-01, an in vitro diagnostic (IVD) test used to measure human follicle stimulating hormone (FSH) concentration in serum or plasma. The recall is due to invalid calibration with low calibrator S1 while using the product.
The affected product is intended for use on the VIDAS family of instruments (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA). It is used as an aid in the diagnosis of pituitary gland and gonadal disorders. The firm name on the label is bioMerieux SA, France.
A total of 59 units were distributed to the U.S. Lot #1005888210 was distributed in the U.S. Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution. The agency classification for this recall is Class II.
The recalled product
- Product
- VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human
- Manufacturer
- BioMerieux SA
- Hazard
- Affected units
- 59
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)
- Lot #1005888210 was distributed in the U.S.
Distribution
Distributed in 1 state:
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