Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VIDAS FSH Recalled by BioMerieux SA Due to Invalid calibration with low calibrator S1 while using...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BioMerieux SA directly.
Affected Products
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 follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.
Quantity: 59 units distributed to the U.S.
Why Was This Recalled?
Invalid calibration with low calibrator S1 while using the product.
Where Was This Sold?
This product was distributed to 1 state: KY
About BioMerieux SA
BioMerieux SA has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report