Events

Safety Alert for ESTRADIOL II, ESTRADIOL III

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE S.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
    Safety alert
  • Event ID
    IRD-040216
  • Event Number
    INVIMA 2006RD-0000010 ; INVIMA 2015RD-0003164
  • Date
    2016-02-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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
    An "urgent safety notice" published by another commercial home was received stating that the drug "fulvestrant" could cause high results with its estradiol (e2) assay. based on this information, roche diagnostics has tested this interference / cross-reactivity for our e2 assay, identifying an impact of the drug fulvestrant on the results of patient samples with bothelecsys® estradiol trials (estradiol ii and estradiol iii), which can not be excluded.

Device

ESTRADIOL II, ESTRADIOL III

Manufacturer

ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE S.A.