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.
Invalid calibration with low calibrator S1 while using the product.
Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2018