BEUDAMED
    FDA Recall Terminated

    Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.

    Recall: Z-1783-2010 · Initiated February 12, 2010

    Recall

    Recall Number
    Z-1783-2010
    Event Number
    54630
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 12, 2010
    Posted
    June 10, 2010
    Terminated
    July 22, 2011
    Address
    200 Prospect St, Waltham, MA, 02453

    Description

    Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.

    Reason

    Glucose strips report low glucose results

    Action

    Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.

    Distribution

    Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.

    Quantity

    392 Cases (1800 strips each)