BEUDAMED
    FDA Enforcement Class II Terminated

    PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054

    Recall: Z-1361-2014 · Reported April 16, 2014

    Enforcement

    Recall Number
    Z-1361-2014
    Event ID
    67665
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LumiQuick Diagnostics Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 16, 2014
    Initiation Date
    March 4, 2014
    Classification Date
    April 7, 2014
    Termination Date
    May 9, 2014
    Address
    2946 Scott Blvd, N/A, Santa Clara, CA, 95054-3312, United States

    Description

    PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054

    Reason

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

    Code Info

    Catalog number: 72003, All lots

    Distribution

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

    Quantity

    ALL