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.
FDA Recall Z-2331-2018 · Posted 2018-06-29
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Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodeCGJ
Date Initiated2018-04-09
Date Terminated2025-12-02
Product Quantity59 units distributed to the U.S.
Reason for Recall
Invalid calibration with low calibrator S1 while using the product.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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