Events

Recall of Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module

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
    26678
  • Event Risk Class
    Class 2
  • Event Number
    Z-1090-03
  • Event Initiated Date
    2003-06-16
  • Event Date Posted
    2003-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28144
  • 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 allows patient reports to contain incomplete data used for diagnosis or treatment.
  • Action
    The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.

Device

Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
  • Model / Serial
    Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.
  • Product Description
    Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
  • Manufacturer
    Misys Healthcare Systems

Manufacturer

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