BEUDAMED
    FDA Recall Terminated

    CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.

    Recall: Z-0819-2010 · Initiated August 12, 2009

    Recall

    Recall Number
    Z-0819-2010
    Event Number
    53025
    Firm
    Veridex, LLC
    FEI Number
    3004619490
    Product Code
    NQI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2009
    Posted
    February 23, 2010
    Terminated
    July 18, 2012
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606

    Description

    CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company.

    Reason

    Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression may occur due to false low CTC results.

    Action

    Urgent Product Correction Notification letters were sent to all customers on August 12, 2009 by Federal Express. Customers were advised to inspect the kits to assure the proper reagents are in the proper position. If not, do not use the kits and contact the company at 877-837-4339 (chose option 1).

    Distribution

    Product was distributed worldwide, US (one government account: National Cancer Institute, Frederick, MD). Also 8 international accounts in Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel.

    Quantity

    1641 in US, 380 internationally.