BEUDAMED
    FDA Enforcement Class II Terminated

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    Recall: Z-0251-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0251-2013
    Event ID
    63380
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    November 19, 2009
    Classification Date
    November 6, 2012
    Termination Date
    November 6, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    Description

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    Reason

    The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.

    Code Info

    v3.0.0_07222004 and later

    Distribution

    Nationwide Distribution.

    Quantity

    9 units