Events

Safety Alert for HIV test kit 1&2

According to National Drugs Administration from El Salvador (DNM), this safety alert involved a device in El Salvador that was produced by Hangzhou Clongene Biotech Co. Ltd.

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 Risk Class
    Class I
  • Date
    2017-02-07
  • Event Country
    El Salvador
  • Event Source
    DNM
  • Event Source URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alerts
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 data from the U.S. and El Salvador.
  • Extra notes in the data
  • Reason
    - no sanitary registry or imports of the product were found, according to the research carried out by the dnm. - include within the list of falfra.
  • Action
    - Notice to the population not to consume the product and inform the National Drugs Administration about the commercialization, distribution or dispensing of this product within any pharmaceutical establishment. - Perform searches of the product in the BPAs or routine searches. - To find the product in existence within the country, a national alert will be issued.

Device

HIV test kit 1&2

Manufacturer

Hangzhou Clongene Biotech Co. Ltd