BioMerieux SA recalls VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of th…

Recall date

April 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2331-2018

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.

Why it was recalled

Invalid calibration with low calibrator S1 while using the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.