BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2099-2021 · Initiated May 10, 2021

    Recall

    Recall Number
    Z-2099-2021
    Event Number
    88130
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JLH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 10, 2021
    Terminated
    November 10, 2021

    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

    Action

    Randox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly. Letter states reason for recall, health risk, and action to take: Action to be taken: " Please discard previous value sheets and ensure standard value is updated. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director

    Distribution

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

    Quantity

    71 kits US