BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.

    Recall: Z-0800-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0800-2014
    Event ID
    67030
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    December 17, 2013
    Classification Date
    January 21, 2014
    Termination Date
    August 26, 2014
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.

    Reason

    An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.

    Code Info

    ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01

    Distribution

    Worldwide Distribution. USA nationwide and the country of Canada.

    Quantity

    1563