BEUDAMED
    FDA Enforcement Class II Terminated

    RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

    Recall: Z-0328-2022 · Reported December 8, 2021

    Enforcement

    Recall Number
    Z-0328-2022
    Event ID
    88999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 8, 2021
    Initiation Date
    November 1, 2021
    Classification Date
    December 1, 2021
    Termination Date
    March 9, 2023
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

    Reason

    When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

    Code Info

    Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130

    Distribution

    US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.

    Quantity

    15 kits