BEUDAMED
    FDA Recall Terminated

    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.

    Recall: Z-0740-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-0740-2016
    Event Number
    73033
    Firm
    Horiba Instruments Inc
    FEI Number
    3002698356
    Product Code
    CFR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 11, 2016
    Posted
    February 2, 2016
    Terminated
    June 7, 2016
    Address
    9755 Research Dr, Irvine, CA, 92618-4626

    Description

    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.

    Reason

    N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.

    Action

    Customer notification letters were sent on 01/11/16. Customers were provided the following instructions/actions: When performing tests that use the Tinder reaction, the blood draw should be done before treatment is given to the patient. Reagent inserts for the concerned HORIBA Medical Products have been updated and now include the following additional warning: Patients treated with N-Acetylcysteine (NAC) for Paracetamol overdose may generate a false low result. The letter request customers share the information with laboratory staff and retain the notification as part of their laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days in order for the firm to verify the understanding of the notice. If any questions contact the local HORIBA Medical representative.

    Distribution

    U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

    Quantity

    216