BEUDAMED
    FDA Recall Terminated

    CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    Recall: Z-2175-2010 · Initiated May 19, 2010

    Recall

    Recall Number
    Z-2175-2010
    Event Number
    55908
    Firm
    Veridex, LLC
    FEI Number
    3004619490
    Product Code
    GKH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 19, 2010
    Posted
    August 5, 2010
    Terminated
    May 8, 2014
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606

    Description

    CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    Reason

    Complaints of patient sample carryover.

    Action

    On 19 May 2010, all consignees were notified, US and foreign, via Urgent Product Correction Notification letters. The letter identified the affected product and explained the reason for recall. Customers were asked to follow the required actions provided in the letter, including completing and returning the attached Confirmation of Receipt form. Questions should be directed to Customer Technical Services at 1-877-837-4339.

    Distribution

    Worldwide distribution -- USA, China, Japan, England, France, Germany, Italy, Spain and Canada.

    Quantity

    101 Domestically, 87 Internationally