Events

Recall of Sunquest Laboratory System.

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
    49136
  • Event Risk Class
    Class 2
  • Event Number
    Z-0214-2009
  • Event Initiated Date
    2008-08-01
  • Event Date Posted
    2008-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72843
  • 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. - Product Code JQP
  • Reason
    While performing in-house testing for the sunquest laboratory system and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (cache)was not communicated or displayed in the graphic user interface (gui) application so the activity continued. while this error was registered in the error log in the system u.
  • Action
    A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.

Device

Sunquest Laboratory System.
  • Model / Serial
    Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.
  • Product Description
    Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. || The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.
  • Manufacturer
    Sunquest Information Systems, Inc.

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