BEUDAMED
    FDA Recall Terminated

    Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA

    Recall: Z-1102-2007 · Initiated April 17, 2007

    Recall

    Recall Number
    Z-1102-2007
    Event Number
    38206
    Firm
    Veridex, LLC
    FEI Number
    3004582358
    Product Code
    NQI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2007
    Posted
    July 24, 2007
    Terminated
    December 6, 2007
    Address
    33 Technology Dr, Warren, NJ, 07059-5148

    Description

    Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA

    Reason

    An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.

    Action

    All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.

    Distribution

    The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.

    Quantity

    Lot 0036: 468 kits; Lot 0036A: 197 kits