BEUDAMED
    FDA Enforcement Class II Terminated

    Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.

    Recall: Z-2671-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2671-2016
    Event ID
    64796
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare It
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    November 20, 2012
    Classification Date
    August 26, 2016
    Termination Date
    December 29, 2017
    Address
    540 W Northwest Hwy, N/A, Barrington, IL, 60010-3051, United States

    Description

    Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network.

    Reason

    The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (item) results on the master panel. Additionally, the displayed and HL7 results show neither the appropriate abnormal flag value nor the reference range values, when using large_num.g >7 to report numeric results.

    Code Info

    Versions 4.1, 4.0, 3.3.2 & 3.3Almp

    Distribution

    Worldwide Distribution - US Distribution to GA, OH, NY, TX, TN ,MN and Internationally to India, Australia, Canada, England, Qatar, and Scotland.

    Quantity

    17