BEUDAMED
    FDA Recall Terminated

    BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.

    Recall: Z-1221-03 · Initiated July 23, 2003

    Recall

    Recall Number
    Z-1221-03
    Event Number
    26927
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 23, 2003
    Posted
    September 11, 2003
    Terminated
    December 2, 2004
    Address
    1 Becton Drive, Franklin Lakes, NJ, 07417

    Description

    BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.

    Reason

    Test Strips may not be meeting specifications at the lower range of glucose values.

    Action

    On July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.

    Distribution

    Product was distributed to the Becton Dickinson Canada, Inc.,

    Quantity

    754800 strips