Events

Safety Alert for NucliSENS easyMAG Software

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by bioMerieux.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-11-03
  • Event Date Posted
    2015-11-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151103c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biomerieux nuclisens easymag software medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its nuclisens easymag software [catalogue number: 280106; software version: 2.0]. the manufacturer has identified some anomalies in the affected devices operating on windows xp with easymag software version 2.0. according to the manufacturer, evaluation of the associated anomalies indicates there is no potential for erroneous test results. the manufacturer is implementing a software update, nuclisens easymag software version 2.1, which will resolve the anomalies. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 november 2015.

Device

NucliSENS easyMAG Software
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: bioMerieux NucliSENS easyMAG Software
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux