BEUDAMED
    FDA Enforcement Class III Ongoing

    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

    Recall: Z-0624-2024 · Reported January 10, 2024

    Enforcement

    Recall Number
    Z-0624-2024
    Event ID
    93543
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 10, 2024
    Initiation Date
    November 6, 2023
    Classification Date
    January 2, 2024
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

    Reason

    A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.

    Code Info

    GTIN: 05055273216424 Bath/Lot Number: 157SR

    Distribution

    NY, WV

    Quantity

    1 unit