BEUDAMED
    FDA Enforcement Class II Ongoing

    RANDOX Total Bilirubin.

    Recall: Z-0501-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0501-2024
    Event ID
    93387
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 13, 2023
    Initiation Date
    October 11, 2023
    Classification Date
    December 6, 2023
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    RANDOX Total Bilirubin.

    Reason

    Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

    Code Info

    Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.

    Distribution

    US Nationwide distribution in the states of AR, GA, NC, TN, & PR.

    Quantity

    1644 units