Events

Safety Alert for LIAISON HBsAg kit kit code 310100 - Registration 10339840211 - Lot Affected 040059.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DiaSorin Ltda.

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
    1170
  • Date
    2012-08-28
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    As turbidity in one of its components may indicate possible contamination, use of the affected product although responding as expected may lead to a false positive result. Anvisa is following this action. ### UPDATE - 11/27/2012 - The company announces the closure of Recall. It will present the Certificate of destruction of the products in 12/2012. #### CLOSURE - 02/21/2013 - The company forwards the certificate of destruction of the products collected, thus closing this Field Action.
  • Reason
    Through internal tests, diasorin realized in this lot of liaison hbsag, usable only in the liaison analyzer, that one of its components presents turbidity, which may indicate possible contamination.
  • Action
    Suspend the use of the product, restrict the product and return the unused products to DiaSorin Ltda that will send them for destruction.

Device

LIAISON HBsAg kit kit code 310100 - Registration 10339840211 - Lot Affected 040059.

Manufacturer

DiaSorin Ltda