BEUDAMED
    FDA Recall Terminated

    Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054

    Recall: Z-1363-2014 · Initiated March 4, 2014

    Recall

    Recall Number
    Z-1363-2014
    Event Number
    67665
    Firm
    LumiQuick Diagnostics Inc.
    FEI Number
    3005984081
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    March 4, 2014
    Posted
    April 7, 2014
    Terminated
    May 9, 2014
    Address
    2946 Scott Blvd, Santa Clara, CA, 95054-3312

    Description

    Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054

    Reason

    Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.

    Action

    Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.

    Distribution

    Distributed in the states of CA, FL, NJ, TX, and NY.

    Quantity

    ALL