Events

Recall Or Safety Alert for The analyzer of blood gases of the ABL 800 FLEX series with accessories

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Radiometer Medical APS, DENMARK.

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-7.97009
  • Date
    2014-05-02
  • 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
    The company radiometer medical aps has learned that the outer shell of some membranes for analyzers of blood gases of the abl 800 flex series can contain enzymes, which leads to inaccuracy in the indication of results. in case of questions from users, they can contact the distributor.

Device

The analyzer of blood gases of the ABL 800 FLEX series with accessories

Manufacturer

Radiometer Medical APS, DENMARK