BEUDAMED
    FDA Recall Terminated

    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

    Recall: Z-1328-2009 · Initiated August 11, 2008

    Recall

    Recall Number
    Z-1328-2009
    Event Number
    49127
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CGL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 11, 2008
    Posted
    May 7, 2009
    Terminated
    July 22, 2011
    Address
    200 Prospect St, Waltham, MA, 02453-3457

    Description

    Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.

    Reason

    Erroneous, low creatinine results on CCX analyzer

    Action

    Initial: USA and Canada - Customer Advisory Notice notification by phone contact with key customer contact facilitated using a Field Correction Script. This contact will be documented within the Nova Biomedical Technical Support database (Pivotal) and on a Field Correction Checklist. All affected inventory will be replaced at customer sites. International - Customer Advisory Notice and Faxback Form being communicated and sent to Nova Biomedical Subsidiaries and Distributors by three methods of delivery (Email, Fax and Phone Call). Follow-up: USA and Canada - Sending the Customer Advisory Notice by email and/or fax to the key customer contact from the initial phone contact. International - Sending the Customer Advisory Notice by email and/or fax to the key contact.

    Distribution

    Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.

    Quantity

    1230