BEUDAMED
    FDA Enforcement Class II Ongoing

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

    Recall: Z-1017-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-1017-2025
    Event ID
    96043
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories, Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 29, 2025
    Initiation Date
    December 20, 2024
    Classification Date
    January 23, 2025
    Address
    Ardmore; 55 The Diamond Road, Crumlin, N/A, United Kingdom

    Description

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

    Reason

    Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

    Code Info

    UDI-DI: 05055273204421 All lots within expiry

    Distribution

    US Nationwide distribution Including PR.

    Quantity

    15 kits