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.
Hazard
Invalid calibration with low calibrator S1 while using the product.
What You Should Do
Remedy
The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
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 quantitati
- Brand
- BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
- UPC
- Lot #1005888210 was distributed in the U.S.
Units Affected
59 units distributed to the U.S.