Events

Recall of Misys Commercial Laboratory, Laboratory Information System, version 3.4.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Misys Healthcare 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
    26042
  • Event Risk Class
    Class 3
  • Event Number
    Z-0806-03
  • Event Initiated Date
    2003-03-24
  • Event Date Posted
    2003-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26921
  • 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 logic error.
  • Action
    The firm wrote and installed code to correct the problem on 3/13/2003. Recall is complete.

Device

Misys Commercial Laboratory, Laboratory Information System, version 3.4.1
  • Model / Serial
    Version 3.4.1
  • Distribution
    Only to one account in Chester, SC.
  • Product Description
    Misys Commercial Laboratory, Laboratory Information System, version 3.4.1
  • Manufacturer
    Misys Healthcare Systems

Manufacturer

Misys Healthcare Systems
  • Manufacturer Address
    Misys Healthcare Systems, 101 East Park Blvd, Plano TX 75074
  • Source
    USFDA