Recall of Misys Laboratory

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.
  • Action
    Notice of recall was sent by fax on October 18, 2002. A software fix will be available for version 5.3 in January 2003. Users will be notified again of this new release and be urged to update from version 5.23 to version 5.3. Completion of the recall is estimated to be in March 2003.


  • Model / Serial
    Versions 5.23 and 5.3 with Callback.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and to the United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, and United Arab Emirates,
  • Product Description
    Misys Laboratory versions 5.23 and 5.3 with Callback
  • Manufacturer


  • Manufacturer Address
    Sunquest Information Systems, 4801 E Broadway Blvd, Tucson AZ 85711
  • Source