Events

Safety Alert for Estriadol

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING || CO. LTD (SNIBE CO LTD) || Importer: VELEZ LAB 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
    RRD-090316
  • Event Number
    INVIMA 2012RD-0002389
  • Date
    2016-03-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • 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
    Preliminarily the manufacturer warned about reports that the reagent of lot 015150814 has low analyte recovery that leads to results below expectations. it was immediately processed to carry out the withdrawal action of the product. subsequently the manufacturer confirms recent official commendation that some of the reagent cartridges of the aforementioned batch may have low results (<5.0 ng / ml). the manufacturer reports that the possible cause is a reaction of the displacement reagent seal material with the reagent components. potential risk: confusion in the interpretation of the results.

Device

Estriadol

Manufacturer

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING || CO. LTD (SNIBE CO LTD) || Importer: VELEZ L...