Events

Recall of Misys Laboratory, || Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) || Misys Laboratory GUI Version 5.3

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
    25499
  • Event Risk Class
    Class 2
  • Event Number
    Z-0678-03
  • Event Initiated Date
    2003-01-17
  • Event Date Posted
    2003-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25931
  • 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. graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
  • Action
    Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready.

Device

Misys Laboratory, || Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) || Misy...
  • Model / Serial
    Version 5.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
  • Product Description
    Misys Laboratory, || Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) || Misys Laboratory GUI Version 5.3
  • Manufacturer
    Misys Healthcare Systems

Manufacturer

Misys Healthcare Systems
  • Manufacturer Address
    Misys Healthcare Systems, 4801 E Broadway Blvd, Tucson AZ 85711
  • Source
    USFDA