BEUDAMED
    FDA Recall Terminated

    VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.

    Recall: Z-0833-2013 · Initiated September 28, 2012

    Recall

    Recall Number
    Z-0833-2013
    Event Number
    64244
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 28, 2012
    Posted
    August 6, 2013
    Terminated
    February 24, 2016
    Address
    1910 E Innovation Park Dr, Oro Valley, AZ, 85755-1962

    Description

    VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ hybridization reagents.

    Reason

    Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and u

    Action

    The firm, Roche sent a "Technical Bulletin" and an letter dated October 3, 2012 to its customers. The letter and bulletin described the product, problem and actions to be taken. The customers were informed that Ventana is aggressively working on solutions to this issue. Until mitigations to the overflow condition are available for implementation; inform all personnel in your organization that work with the BenchMark ULTRA or DISCOVERY ULTRA instrument about the potential for fluid overflow to occur during decontamination cycles; follow the instructions provided in the letter to avoid the documented failure mode and follow the instructions provided in the technical bulletin. Contact your local support center with any questions or concerns or call 520-877-7191.

    Distribution

    Worldwide distribution: USA (nationwide) and country of: Germany.

    Quantity

    1735 instruments