Events

Safety Alert for COBAS Gas and Electrolyte Analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Roche Diagnostics International Ltd || Roche Diagnostics Graz GMBH || Roche Diagnostics GMBH.

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
  • Event ID
    I1402-74
  • Event Number
    INVIMA 2009DM-0003181
  • Date
    2014-02-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=209
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    He mentions that there is a potential risk associated with the use of delelectrode reference, since the kcl solution can escape slowly from the electrode creating an electrode parallel to the reference, situation that can cause a change in the ph and sodium readings, leading to potential events adverse on the patient.

Device

COBAS Gas and Electrolyte Analyzer

Manufacturer

Roche Diagnostics International Ltd || Roche Diagnostics Graz GMBH || Roche Diagnostics GMBH