Z-2331-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2018
- Initiation Date
- April 9, 2018
- Termination Date
- December 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units distributed to the U.S.
Product Description
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.
Reason for Recall
Invalid calibration with low calibrator S1 while using the product.
Distribution Pattern
Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Code Information
Lot #1005888210 was distributed in the U.S.