BEUDAMED
    FDA Enforcement Class II Terminated

    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

    Recall: Z-2099-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2099-2021
    Event ID
    88130
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 28, 2021
    Initiation Date
    May 10, 2021
    Classification Date
    July 20, 2021
    Termination Date
    November 10, 2021
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

    Reason

    Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples

    Code Info

    Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066

    Distribution

    US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX

    Quantity

    71 kits US