BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0073-2013 · Initiated November 15, 2011

    Recall

    Recall Number
    Z-0073-2013
    Event Number
    62516
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 15, 2011
    Posted
    October 17, 2012
    Terminated
    October 19, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    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.

    Action

    Urgent - Product Safety Notice: PSN-11-06,dated, 15 November 2011, was sent to customers. Costumers should follow instructions in the notification letter. To request the software correction, create a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Return receipt acknowledging PSN-11-06 is required . Client Support can be reached at 1-877-239-6337 for U.S. and Canadian sites and at +44 (0) 161 335 0562 for International sites.

    Distribution

    Nationwide distribution

    Quantity

    127 sites