Events

Recall of Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2.

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
    26789
  • Event Risk Class
    Class 2
  • Event Number
    Z-0151-04
  • Event Initiated Date
    2003-07-07
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28451
  • 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 defect causes orders to be lost under certain conditions of use. a typographical error at the accept/modfy/reject prompt will cause the order not to be processed by the system.
  • Action
    Product Safety Notice PSN-03-L32 was issued by fax to customers on July 7, 2003. It communcated a procedural workaround and that a follow-up notification was pending completion of a software engineering project to correct the defect.

Device

Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2.
  • Model / Serial
    Versions 5.2, 5.23, 5.3 up to 5.3.2.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to United Kingdom, Ireland, Denmark, Canada, Bermuda, Saudi Arabia, United Arab Emirates,
  • Product Description
    Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2.
  • Manufacturer
    Misys Healthcare Systems

Manufacturer

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