FDA-Device2018-07-04Class II
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.
BioMerieux SA
Hazard
Invalid calibration with low calibrator S1 while using the product.
Sold states
Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Affected count
59 units distributed to the U.S.
Manufactured in
Chemin De L'Orme, Marcy L'Etoile, France
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2018Don't want to check this manually?
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