BEUDAMED
    FDA Enforcement Class II 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 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2331-2018
    Event ID
    79620
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    April 9, 2018
    Classification Date
    June 28, 2018
    Termination Date
    December 2, 2025
    Address
    Chemin De L'Orme, Marcy L'Etoile, N/A, France

    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.

    Code Info

    Lot #1005888210 was distributed in the U.S.

    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.