Events

Recall Or Safety Alert for Reagents and consumables for immunological immunological analyzers

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Siemens Healthcare Diagnostics, Inc., UNITED STATES OF AMERICA.

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
    Recall / Safety alert
  • Event Number
    ИМ-7.99322
  • Date
    2012-08-31
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 recall data from the U.S. and Belarus.
  • Extra notes in the data
  • Reason
    Due to the increasing number of consumer complaints that the immulite analyzer produces false-positive results of thyroid hormone in healthy people when using reagent t3 free from some batches, the manufacturer recommends not to use certain batches of these reagents and contact your regional distributor.

Device

Reagents and consumables for immunological immunological analyzers

Manufacturer

Siemens Healthcare Diagnostics, Inc., UNITED STATES OF AMERICA