BEUDAMED
    FDA Recall Terminated

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

    Recall: Z-2229-2012 · Initiated August 12, 2011

    Recall

    Recall Number
    Z-2229-2012
    Event Number
    62452
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 12, 2011
    Posted
    August 21, 2012
    Terminated
    September 4, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    Description

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use

    Reason

    In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.

    Action

    Sunquest sent an Urgent - Product Safety Notice letter dated August 12, 2011 to all affected customers. The letter identified the affected product, summary of the problem, actions to eliminate the problem and actions to be taken by clients. Sunquest will distribute a new maintenance release. Client Support can be reached at 1-877-239-0337 for U.S and Canadian sites and at +44 (0) 101-335-0562 for international sites.

    Distribution

    US Nationwide Distribution

    Quantity

    47 sites