BEUDAMED
    FDA Recall 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 · Initiated December 17, 2013

    Recall

    Recall Number
    Z-0800-2014
    Event Number
    67030
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 17, 2013
    Posted
    January 21, 2014
    Terminated
    August 26, 2014
    Address
    500 Gbc Dr PO BOX 6101, Ms 514, Newark, DE, 19702-2466

    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.

    Action

    The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.

    Distribution

    Worldwide Distribution. USA nationwide and the country of Canada.

    Quantity

    1563