BEUDAMED
    FDA Enforcement Class II 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 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1267-2018
    Event ID
    77160
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    April 11, 2017
    Classification Date
    March 28, 2018
    Termination Date
    August 20, 2019
    Address
    5 Oak Park Dr, Bedford, MA, 01730-1430, United States

    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.

    Code Info

    Medica s Lot # 16292

    Distribution

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