Events

Safety Alert for MUREX HTLV I / II

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott labs do brasil 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
    667
  • Date
    2002-08-01
  • 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
    Art. 10, items XV and XXIX of Art. 10, of Law no. 6.437, of August 20, 1977; Law 6.360 / 76 Article 67, item I; Decree No. 79.094 / 77 - Art. 94 para. 1; Portaria 8/96 SVS - Annex IV e V, Administrative Proceeding no. 25351 - 038045/01 - 34, which determined the penalties of fine, warning and prohibition of the product, due to the sanitary violation contained in AIS 11/2001-GGTPS , of November 23, 2001, for marketing the Murex HTLV I / II brand product without having the Portuguese language instructions in the instruction manual.
  • Reason
    By not presenting a user manual with instructions in portuguese,.
  • Action
    Determine, as a measure of health interest, throughout the national territory, the prohibition of the product Murex HTLV I / II that does not present instructions manual in Portuguese language, until the responsible company adopts the appropriate measures

Device

MUREX HTLV I / II

Manufacturer

Abbott labs do brasil ltda
  • Source
    ANVSANVISA