BEUDAMED
    FDA Recall Terminated

    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.

    Recall: Z-2118-2013 · Initiated June 12, 2008

    Recall

    Recall Number
    Z-2118-2013
    Event Number
    49516
    Firm
    Ventana Medical Systems Inc
    FEI Number
    1000125183
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 12, 2008
    Posted
    August 28, 2013
    Terminated
    August 29, 2013
    Address
    1910 E Innovation Park Dr, Tucson, AZ, 85755

    Description

    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.

    Reason

    Ventana Medical System is initiating the recall of the BenchMark and DISCOVERY series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. Additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.

    Action

    Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.

    Quantity

    1217 units total