BEUDAMED
    FDA Recall Terminated

    HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France

    Recall: Z-0073-2007 · Initiated August 29, 2006

    Recall

    Recall Number
    Z-0073-2007
    Event Number
    36413
    Firm
    Sebia, Inc.
    FEI Number
    3001595416
    Product Code
    JBD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2006
    Posted
    October 25, 2006
    Terminated
    January 28, 2010
    Address
    400-1705 Corporate Dr., Norcross, GA, 30093

    Description

    HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France

    Reason

    The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.

    Action

    Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.

    Distribution

    Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico

    Quantity

    71 kits