Events

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
    Recall
  • Event ID
    25010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0324-03
  • Event Initiated Date
    2002-10-18
  • Event Date Posted
    2002-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25011
  • 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.

Device

Misys Laboratory
  • Model / Serial
    Versions 5.23 and 5.3 with Callback.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
    Sunquest Information Systems

Manufacturer

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