Recall Z-2331-2018 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
BioMerieux SA
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
| Date | Jun 29, 2018 (initiated Apr 9, 2018) |
| Status | Terminated |
| Reason | Invalid calibration with low calibrator S1 while using the product. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 59 units distributed to the U.S. |
| Distribution | Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Biomerieux Vitek, Inc., Jun 16, 1992 |