Events

Alerta De Seguridad para MUREX HTLV I / II

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott labs do brasil ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    667
  • Fecha
    2002-08-01
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    By not presenting a user manual with instructions in portuguese,.
  • Acción
    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