BEUDAMED
    FDA Enforcement Class I Terminated

    ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.

    Recall: Z-2021-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2021-2014
    Event ID
    68196
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    DIABETIC SUPPLY OF SUNCOAST, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    May 5, 2014
    Classification Date
    July 22, 2014
    Termination Date
    June 13, 2017
    Address
    Barrio Espinosa Road #2 Km 26.2, Dorado, PR, 00646, United States

    Description

    ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.

    Reason

    "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips".

    Code Info

    All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Venezuela, Ecuador, Canada & Vietnam

    Quantity

    1,852,800 cases (50 strips ea)