BEUDAMED
    FDA Enforcement Class II Terminated

    TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

    Recall: Z-2201-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2201-2020
    Event ID
    85535
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trividia Health, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    June 10, 2020
    Initiation Date
    April 20, 2020
    Classification Date
    June 1, 2020
    Termination Date
    June 1, 2021
    Address
    2400 NW 55th Ct, N/A, Ft Lauderdale, FL, 33309-2672, United States

    Description

    TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.

    Reason

    One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL.

    Code Info

    Serial Number TA1548753

    Distribution

    US Nationwide distribution including in the state of Florida.

    Quantity

    1 unit