FDAFDA · Food and drugs·Recall number Z-2331-2018
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.
Published July 4, 2018 · Recall initiated: April 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Invalid calibration with low calibrator S1 while using the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioMerieux SA
- Distributor
- Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
- Lot
- Lot #1005888210 was distributed in the U.S.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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