BEUDAMED
    FDA Recall Terminated

    Sunquest Laboratory LabAccess Results Workstation (LARS)

    Recall: Z-2272-2012 · Initiated October 5, 2010

    Recall

    Recall Number
    Z-2272-2012
    Event Number
    62714
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 5, 2010
    Posted
    August 24, 2012
    Terminated
    August 24, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    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.

    Action

    An "Urgent - Product safety notice " was issued on 11/4/10 to all customers who purchased the Sunquest Laboratory LabAccess Results Workstation (LARS). The safety notice informed the customers of the problems identified and the actions to be taken. US customers may contact 1-877-239-6337.

    Distribution

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

    Quantity

    151 sites