BEUDAMED
    FDA Enforcement Class III Terminated

    Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

    Recall: Z-2216-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2216-2012
    Event ID
    62344
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 22, 2012
    Initiation Date
    April 28, 2011
    Classification Date
    August 16, 2012
    Termination Date
    September 4, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472, United States

    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 (<Y>/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

    Code Info

    Version 6.3.0 and Later

    Distribution

    Nationwide Distribution

    Quantity

    103 sites