BEUDAMED
    FDA Enforcement Class II Terminated

    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.

    Recall: Z-2169-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2169-2018
    Event ID
    80111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioMerieux SA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    March 23, 2018
    Classification Date
    June 12, 2018
    Termination Date
    June 23, 2020
    Address
    Chemin De L'Orme, N/A, Marcy L'Etoile, N/A, N/A, France

    Description

    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.

    Reason

    A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

    Code Info

    VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420

    Distribution

    International distribution.

    Quantity

    2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS