BEUDAMED
    FDA Recall Terminated

    Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.

    Recall: Z-1397-2009 · Initiated November 17, 2008

    Recall

    Recall Number
    Z-1397-2009
    Event Number
    50201
    Firm
    GE Healthcare Integrated IT Solutions
    FEI Number
    3004526608
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 17, 2008
    Posted
    May 15, 2009
    Terminated
    September 11, 2010
    Address
    540 W Northwest Hwy, Barrington, IL, 60010-3051

    Description

    Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010 The Centricity TriWin Laboratory product is a laboratory information system. It is designed to facilitate the general clinical, anatomic pathology, and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval.

    Reason

    A software defect in the Centricity Lab (TriWin) product may incorrectly link patient information to a wrong report. Also, when viewing results in Patient Viewer, and a coagulation result is higher or lower than the linearity limit, then all of the results following the higher or lower result will show the same result as the first flagged result.

    Action

    GE Healthcare notified their Centricity TriWin Laboratory customer via letter dated 11/17/08 of the software anomalies resulting in patient safety issues involving the patient information incorrectly being linked to a wrong report, and when viewing results in Patient Viewer, and a coagulation result is outside of a linearity limit, then all of the results following the out of linearity result will show the same result as the first flagged result. The user was informed that a software patch has been prepared to resolve the issues and will be installed on their system. Any questions were directed to GE Technical Support at 888-778-3375 or 905-479-1249, select option 1. The accounts was requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax it back to 905-305-0046 to schedule the software upgrade.

    Distribution

    Worldwide Distribution -- USA and country of Canada.

    Quantity

    26 units