Events

Recall of Misys Laboratory with Lab Access Results application for versions 5.3 and later.

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
    32174
  • Event Risk Class
    Class 2
  • Event Number
    Z-0938-05
  • Event Initiated Date
    2005-05-13
  • Event Date Posted
    2005-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39293
  • 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 anomaly may rarely allow modification of previously reported specimen results.
  • Action
    Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.

Device

Misys Laboratory with Lab Access Results application for versions 5.3 and later.
  • Model / Serial
    Versions 5.3 and later.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and United Kingdom, Ireland, Denmark, Canada, Saudi Arabia, United Arab Emirates
  • Product Description
    Misys Laboratory with Lab Access Results application for versions 5.3 and later.
  • Manufacturer
    Misys Healthcare Systems

Manufacturer

Misys Healthcare Systems
  • Manufacturer Address
    Misys Healthcare Systems, 4801 E Broadway Blvd, Tucson AZ 85711-3609
  • Source
    USFDA