BEUDAMED
    FDA Recall Terminated

    MAS Omni Immune PRO Controls

    Recall: Z-1930-2014 · Initiated December 2, 2013

    Recall

    Recall Number
    Z-1930-2014
    Event Number
    67011
    Firm
    Microgenics Corporation
    FEI Number
    3010939897
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    December 2, 2013
    Posted
    June 26, 2014
    Terminated
    July 8, 2014
    Address
    44660 Osgood Rd, Fremont, CA, 94539-6410

    Description

    MAS Omni Immune PRO Controls

    Reason

    The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.

    Action

    Urgent Medical Device Correction letters were sent on December 2, 2013 to all affected customers and distributors via trackable mail.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, China, Germany, Hong Kong and Malaysia.

    Quantity

    1393