BEUDAMED
    FDA Enforcement Class II Ongoing

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    Recall: Z-1328-2024 · Reported March 27, 2024

    Enforcement

    Recall Number
    Z-1328-2024
    Event ID
    94187
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 27, 2024
    Initiation Date
    March 1, 2024
    Classification Date
    March 20, 2024
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    Reason

    The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

    Code Info

    Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)

    Distribution

    Domestic: CA, FL, IL, ME, NJ, OH, & OR.

    Quantity

    1,764 units