Events

Safety Alert for ORTHO HIV-1 / HIV-2 Ab - capture Elisa Test System

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Rem industria e comercio 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
    666
  • 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
    § 3, of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; 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 and V; Administrative Proceeding no. 25351 - 038046/01 - 05, which determined the penalties of fine, warning and prohibition of the product, due to the sanitary infraction contained in AIS No. 10/2001-GGTPS of November 23, 2001, for marketing the ORTHO HIV-1 / HIV-2 Ab-capture Elisa Test System product without the instructions in Portuguese, until the company in question adopts the appropriate measures.
  • Reason
    Does not have an instruction manual in portuguese.
  • Action
    Determine, as a measure of health interest, throughout the national territory, the prohibition of the product ORTHO HIV-1 / HIV-2 Ab-capture Elisa Test System that does not present instructions manual in Portuguese language, until the company in question adopts the appropriate measures to the case.

Device

ORTHO HIV-1 / HIV-2 Ab - capture Elisa Test System

Manufacturer

Rem industria e comercio ltda
  • Source
    ANVSANVISA