BEUDAMED
    FDA Recall Terminated

    Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    Recall: Z-3181-2011 · Initiated July 26, 2011

    Recall

    Recall Number
    Z-3181-2011
    Event Number
    59677
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    NJT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 26, 2011
    Posted
    September 9, 2011
    Terminated
    September 9, 2011
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0535; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The CDX2 (AMT28) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CDX2 protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

    Reason

    There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.

    Action

    Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm.

    Distribution

    Nationwide Distribution-in the states of Indiana and Kentucky.

    Quantity

    3 units