Device product
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.
Z-2331-2018
Product summary
- Firm
- BioMerieux SA
- Event
- Event 79620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 units distributed to the U.S.
- Official record key
device-enforcement:Z-2331-2018
Official wording
Reason: Invalid calibration with low calibrator S1 while using the product.
Code information: Lot #1005888210 was distributed in the U.S.
Distribution pattern: Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Derived failure modes
-
Unknown
Invalid calibration with low calibrator S1 while using the product.