BEUDAMED
    FDA Recall Terminated

    CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

    Recall: Z-1004-2012 · Initiated August 17, 2011

    Recall

    Recall Number
    Z-1004-2012
    Event Number
    60943
    Firm
    Veridex, LLC
    FEI Number
    3004619490
    Product Code
    NQI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 17, 2011
    Posted
    February 13, 2012
    Terminated
    June 17, 2015
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606

    Description

    CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

    Reason

    Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.

    Action

    Veridex, LLC sent an "URGENT PRODUCT CORRECTION NOTIFICATION" letter dated August 17, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter provides procedure sheets with step by step directions for customers to follow. Additionally, a Confirmation of Receipt form was enclosed for customers to complete and return to the firm. Contact Customer Technical Services at 1-877-837-4339 for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    37 Units