BEUDAMED
    FDA Recall Terminated

    ThermoFisher Scientific Microm STP 420D automated tissue processor.

    Recall: Z-1320-2010 · Initiated June 3, 2009

    Recall

    Recall Number
    Z-1320-2010
    Event Number
    52175
    Firm
    Thermo Fisher Scientific
    FEI Number
    3006339565
    Product Code
    IEO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 3, 2009
    Posted
    April 12, 2010
    Terminated
    June 29, 2011
    Address
    4481 Campus Dr, Kalamazoo, MI, 49008-2590

    Description

    ThermoFisher Scientific Microm STP 420D automated tissue processor.

    Reason

    The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration.

    Action

    Consignees were notified of the problem by letter, on or about 6/3/09, updating the instructions for use. The units were subsequently upgraded on or before 9/8/09. For additional questions and information, please contact ThermoFisher's Technical Support department , Subject: PT Module Advisory Notice.

    Distribution

    Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.

    Quantity

    16