U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Invalid calibration with low calibrator s1 while using the product.
조치
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.
Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
제품 설명
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, 376, Chemin de l'Orme, 69280 March-l'Etoile - France. || Intended 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.