BEUDAMED
    FDA Enforcement Class II Terminated

    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.

    Recall: Z-1119-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1119-2013
    Event ID
    64610
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 13, 2013
    Classification Date
    April 15, 2013
    Termination Date
    March 5, 2015
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.

    Reason

    Negative bias in patient samples for Vitamin D

    Code Info

    Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013

    Distribution

    Nationwide Distribution.

    Quantity

    3871