BEUDAMED
    FDA Enforcement Class II 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 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2406-2015
    Event ID
    71673
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Veridex, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    May 15, 2015
    Classification Date
    August 18, 2015
    Termination Date
    March 30, 2016
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606, United States

    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.

    Code Info

    Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12

    Distribution

    Nationwide Distribution.

    Quantity

    1560 kits