BEUDAMED
    FDA Recall 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 · Initiated May 5, 2014

    Recall

    Recall Number
    Z-2021-2014
    Event Number
    68196
    Firm
    DIABETIC SUPPLY OF SUNCOAST, INC. Barrio
    FEI Number
    3005861699
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 5, 2014
    Posted
    July 22, 2014
    Terminated
    June 13, 2017
    Address
    Espinosa Road, # 2 Km 26.2, Dorado, PR, 00646

    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".

    Action

    Diabetic Supply of Suncoast, Inc. sent an Urgent Voluntary Medical Device Recall letter dated June 6, 2014, to all affected consignees. The firm is asking the distributors to examine their inventory immediately and quarantine any product subject to recall. In addition, if they may have further distributed this product, to please identify their customers and notify them at once of this product recall. Customers who have the BMB-BA006A Advocate Redi-Code+ test strips can contact Diabetic Supply of Suncoast, Inc. directly for further information to determine if the products are being used in the proper manner or if they need to be returned to Suncoast for replacement. Test strips will be replaced with relabeled (with new labels) boxes of test strips to avoid any chance of confusion. Consumers should stop using the above mentioned product and contact Suncoast to find out if this recall pertains to the products they have in their possession and if so how to have them replaced for the relabeled product manufactured by BroadMaster Bio-Tech. Customers with questions should call Diabetic Supply of Suncoast, Inc. at 561-296-0488. For questions regarding this recall call 561-254-1007.

    Distribution

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

    Quantity

    1,852,800 cases (50 strips ea)