BEUDAMED
    FDA Recall Terminated

    Sunquest Laboratory, version 7.0 not available

    Recall: Z-0250-2013 · Initiated November 3, 2011

    Recall

    Recall Number
    Z-0250-2013
    Event Number
    63369
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 3, 2011
    Posted
    November 6, 2012
    Terminated
    November 6, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    Description

    Sunquest Laboratory, version 7.0 not available

    Reason

    Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

    Action

    Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers with questions were instructed to call (877) 239-6337 for US and Canadian sites and at +44 (0) 161 335 0562 for international sites. For questions regarding this recall call 520-570-2252.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Ireland

    Quantity

    14 sites