BEUDAMED
    FDA Recall Terminated

    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.

    Recall: Z-1146-2010 · Initiated September 17, 2009

    Recall

    Recall Number
    Z-1146-2010
    Event Number
    53597
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    MVC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 17, 2009
    Posted
    March 16, 2010
    Terminated
    April 22, 2010
    Address
    1910 E Innovation Park Dr, Tucson, AZ, 85755

    Description

    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.

    Reason

    Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.

    Action

    The recall was initiated on 09/17/2009 with Ventana Medical Systems forwarding Urgent Voluntary Medical Device Recall letters to all the affected customers advising them to discontinue the use of lot number 680957 and have their laboratory retest with product from a different lot of PATHWAY HER2 (4B5) any breast cases scored as 0, 1+, or 2+ that were not reflexed to an approved in situ hybridization (ISH) method. Customers were also instructed to contact Ventana Customer Support at 1-800-227-2155 and select 1 for Technical Support to speak to a Customer Support agent who will work with then to replace or credit any product from this specific lot number.

    Distribution

    Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand

    Quantity

    433 units