Events

Recall of HBsAg Rapid Test Cassette

According to Health Andorra, this recall involved a device in Andorra that was produced by Hangzhou Biotest Biotech Co. Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    ARS/2016/11000
  • Date
    2016-07-08
  • Event Country
    Andorra
  • Event Source
    HA
  • Event Source URL
    https://www.salut.ad/alertes/alertes.php?_pagi_pg=18&data1=&data2=&tipus=PRODUCTES%20DE%20DIAGN%D2STIC%20IN%20VITRO%20-%20Retirada&titol=
  • Notes / Alerts
    Data from Andorra is current through November 2018. All of the data comes from Health Andorra, 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 Andorra.
  • Extra notes in the data

Device

HBsAg Rapid Test Cassette

Manufacturer

Hangzhou Biotest Biotech Co. Ltd.