Events

Recall of Mysis Laboratory version 6.1

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
    32231
  • Event Risk Class
    Class 2
  • Event Number
    Z-0939-05
  • Event Initiated Date
    2005-05-10
  • Event Date Posted
    2005-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39417
  • 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
    When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.
  • Action
    Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.

Device

Mysis Laboratory version 6.1

Manufacturer

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