Events

Recall of Mysis Laboratory

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
    27077
  • Event Risk Class
    Class 1
  • Event Number
    Z-0007-04
  • Event Initiated Date
    2003-08-12
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29148
  • 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. clinical laboratory results failing quality assurance were filed directly to a patient's chart without review.
  • Action
    Product Safety Notice, PSN-03-L37 was issued to all affected clients by facsmile. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.

Device

Mysis Laboratory

Manufacturer

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