Recall Or Safety Alert for Blood gas analyzers ABL9

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/A.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Safety warning in relation to the possibility that sensor cassettes can be installed once their expiration date has elapsed in use and may result in obtaining results with a significant overestimation or underestimation of the actual potassium level or with a significant overestimation of pO2 (partial pressure of oxygen), and review of the results of analyzes that would have been performed on ABL9 analyzers after the expiration date of the sensor cassette.


  • Model / Serial
  • Manufacturer


  • Source