BEUDAMED
    FDA Recall Terminated

    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    Recall: Z-2406-2015 · Initiated May 15, 2015

    Recall

    Recall Number
    Z-2406-2015
    Event Number
    71673
    Firm
    Veridex, LLC
    FEI Number
    3004619490
    Product Code
    NQI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 15, 2015
    Posted
    August 18, 2015
    Terminated
    March 30, 2016
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606

    Description

    Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.

    Reason

    Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.

    Action

    Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex.

    Distribution

    Nationwide Distribution.

    Quantity

    1560 kits