BEUDAMED
    FDA Recall Terminated

    EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

    Recall: Z-1267-2018 · Initiated April 11, 2017

    Recall

    Recall Number
    Z-1267-2018
    Event Number
    77160
    Firm
    Medica Corporation
    FEI Number
    1220972
    Product Code
    JIT
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    April 11, 2017
    Terminated
    August 20, 2019
    Address
    5 Oak Park Dr, Bedford, MA, 01730-1430

    Description

    EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet.

    Reason

    Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

    Action

    Consignees were notified of the recall via email bulletin dated 4/11/17. The bulletin informs customers of the issues and explains the actions to be taken.

    Distribution

    USA: MI FL CA TX India, Russia, Puerto Rico, N. Mariana Island/Palau.