BEUDAMED
    FDA Recall Terminated

    Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003

    Recall: Z-1472-2011 · Initiated November 9, 2010

    Recall

    Recall Number
    Z-1472-2011
    Event Number
    57514
    Firm
    Veridex, LLC
    FEI Number
    3004619490
    Product Code
    NRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 9, 2010
    Posted
    March 1, 2011
    Terminated
    March 28, 2014
    Address
    1001 US Route 202, Raritan, NJ, 08869-0606

    Description

    Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003

    Reason

    There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.

    Action

    Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.

    Distribution

    Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.

    Quantity

    122 US, 28 International