Events

Safety Alert for Liaison® Estradiol II Gen

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by DIASORIN INC || Importer: ANNAR DIAGNOSTICA IMPORT S.A.S..

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
    IRD-050716
  • Event Number
    INVIMA 2013RD-0002579
  • Date
    2016-07-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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
    Recently, the cross-reaction of the fulvestrant drug (faslodex®) with estradiol has been identified, leading to falsely elevated results in the tests in which this hormone is determined. this situation is due to the fact that the drug fulvestrant has a chemical structure similar to estradiol, so it can present a cross-reaction with the antibodies used in the immunoassays. fulvestran is indicated in the treatment of post-menopausal women with estrogen-positive receptors recurring in stage 4 breast cancer.

Device

Liaison® Estradiol II Gen

Manufacturer

DIASORIN INC || Importer: ANNAR DIAGNOSTICA IMPORT S.A.S.