Events

Recall of Device Recall Sunquest Laboratory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunquest Information Systems, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63369
  • Event Risk Class
    Class 2
  • Event Number
    Z-0250-2013
  • Event Initiated Date
    2011-11-03
  • Event Date Posted
    2012-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113605
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Sunquest is recalling sunquest laboratory version 7.0 because when saving an accession to a non-current episode/event, a user-defined field can be incorrectly replaced by the current episode/event user-defined data.
  • Action
    Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers with questions were instructed to call (877) 239-6337 for US and Canadian sites and at +44 (0) 161 335 0562 for international sites. For questions regarding this recall call 520-570-2252.

Device

Device Recall Sunquest Laboratory

Manufacturer

Sunquest Information Systems, Inc.
  • Manufacturer Address
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA