BEUDAMED
    FDA Recall Terminated

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    Recall: Z-2216-2012 · Initiated April 28, 2011

    Recall

    Recall Number
    Z-2216-2012
    Event Number
    62344
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 28, 2011
    Posted
    August 16, 2012
    Terminated
    September 4, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    Description

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    Reason

    In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or

    Action

    Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.

    Distribution

    Nationwide Distribution

    Quantity

    103 sites