BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-2229-2012 · Reported August 29, 2012

    Enforcement

    Recall Number
    Z-2229-2012
    Event ID
    62452
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2012
    Initiation Date
    August 12, 2011
    Classification Date
    August 20, 2012
    Termination Date
    September 4, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    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.

    Code Info

    Version 6.4.2

    Distribution

    US Nationwide Distribution

    Quantity

    47 sites