Events

Recall of Sunquest Laboratory LabAccess Results Workstation

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
    62714
  • Event Risk Class
    Class 2
  • Event Number
    Z-2272-2012
  • Event Initiated Date
    2010-10-05
  • Event Date Posted
    2012-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111482
  • 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
    The recall was initiated because sunquest has confirmed that the sunquest laboratory labaccess results workstation (lars) may file results to the wrong patient by incorrectly combining results.
  • Action
    An "Urgent - Product safety notice " was issued on 11/4/10 to all customers who purchased the Sunquest Laboratory LabAccess Results Workstation (LARS). The safety notice informed the customers of the problems identified and the actions to be taken. US customers may contact 1-877-239-6337.

Device

Sunquest Laboratory LabAccess Results Workstation
  • Model / Serial
    Sunquest Laboratory versions 5.3.3 and 6.3.0 SP3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Denmark, Ireland, the United Arab Emirates and the United Kingdom.
  • Product Description
    Sunquest Laboratory LabAccess Results Workstation (LARS)
  • 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