BEUDAMED
    FDA Recall Terminated

    Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc

    Recall: Z-0553-2008 · Initiated October 30, 2007

    Recall

    Recall Number
    Z-0553-2008
    Event Number
    45891
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    KEY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 30, 2007
    Posted
    January 25, 2008
    Terminated
    April 14, 2008
    Address
    1910 E Innovation Park Dr, Tucson, AZ, 85755-1962

    Description

    Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Ventana Medical Systems Inc

    Reason

    Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.

    Action

    The end user customers were verbally contacted starting in November 2007 to set up a scheduled visit to replace the fitting.

    Distribution

    Worldwide-USA, France and Japan

    Quantity

    55