BEUDAMED
    FDA Recall Terminated

    CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.

    Recall: Z-1734-2009 · Initiated May 6, 2009

    Recall

    Recall Number
    Z-1734-2009
    Event Number
    52079
    Firm
    Veridex, LLC
    FEI Number
    3004619490
    Product Code
    GKH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 6, 2009
    Posted
    August 13, 2009
    Terminated
    October 5, 2010
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606

    Description

    CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008.

    Reason

    Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.

    Action

    Veridex, LLC issued a recall notice to consignees dated March 12, 2009 detailing the affected product. The firm will provide replacement bottles to all customers in the near future. For further questions, contact Veridex Customer Technical Services at 1-877-837-4339.

    Distribution

    Worldwide Distribution

    Quantity

    196 instruments