Events

Recall of Misys Laboratory versions 5.23 and 5.3

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
    25212
  • Event Risk Class
    Class 2
  • Event Number
    Z-0423-03
  • Event Initiated Date
    2002-11-22
  • Event Date Posted
    2003-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25394
  • 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
  • Reason
    Software anomally.
  • Action
    A recall notice along witn instructions for avoiding conditions that might cause the observed anomalous results was faxed to all customers 11/22/2002.

Device

Misys Laboratory versions 5.23 and 5.3
  • Model / Serial
    Versions 5.23 and 5.3
  • Distribution
    Nationwide and to the United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates,
  • Product Description
    Misys Laboratory versions 5.23 and 5.3
  • Manufacturer
    Sunquest Information Systems

Manufacturer

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