BEUDAMED
    FDA Recall Terminated

    FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; Part Number: 70672-01; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

    Recall: Z-0604-06 · Initiated February 17, 2006

    Recall

    Recall Number
    Z-0604-06
    Event Number
    34665
    Firm
    Abbott Diabetes Care, Inc.
    FEI Number
    3002803444
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2006
    Posted
    March 15, 2006
    Terminated
    January 20, 2011
    Address
    1360 South Loop Road, Alameda, CA, 94502-7000

    Description

    FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; Part Number: 70672-01; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

    Reason

    The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.

    Action

    On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.

    Distribution

    The product was released for distribution to 28 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

    Quantity

    900