BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2331-2018 · Initiated April 9, 2018

    Recall

    Recall Number
    Z-2331-2018
    Event Number
    79620
    Firm
    BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
    FEI Number
    1000611339
    Product Code
    CGJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 9, 2018
    Posted
    June 29, 2018
    Terminated
    December 2, 2025

    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

    Invalid calibration with low calibrator S1 while using the product.

    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.

    Distribution

    Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.

    Quantity

    59 units distributed to the U.S.