BEUDAMED
    FDA Enforcement Class III Terminated

    MAS Omni Immune PRO Controls

    Recall: Z-1930-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1930-2014
    Event ID
    67011
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microgenics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    December 2, 2013
    Classification Date
    June 26, 2014
    Termination Date
    July 8, 2014
    Address
    44660 Osgood Rd, N/A, Fremont, CA, 94539-6410, United States

    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.

    Code Info

    Part Number Lot number OPR0-101 OPR015101 OPR0-202 OPR015102 OPR0-303 OPR015103 OPRO-SP OPR01510S All lots have an expiration date of 10/31/2015.

    Distribution

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

    Quantity

    1393