BEUDAMED
    FDA Enforcement Class II Terminated

    Sunquest Laboratory LabAccess Results Workstation (LARS)

    Recall: Z-2272-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2272-2012
    Event ID
    62714
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    October 5, 2010
    Classification Date
    August 24, 2012
    Termination Date
    August 24, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    Description

    Sunquest Laboratory LabAccess Results Workstation (LARS)

    Reason

    The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Results Workstation (LARS) may file results to the wrong patient by incorrectly combining results.

    Code Info

    Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3

    Distribution

    Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.

    Quantity

    151 sites