BEUDAMED
    FDA Enforcement Class III Terminated

    Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

    Recall: Z-0073-2013 · Reported October 24, 2012

    Enforcement

    Recall Number
    Z-0073-2013
    Event ID
    62516
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 24, 2012
    Initiation Date
    November 15, 2011
    Classification Date
    October 17, 2012
    Termination Date
    October 19, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    Description

    Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

    Reason

    Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.

    Code Info

    Versions 6.4.0 and later

    Distribution

    Nationwide distribution

    Quantity

    127 sites