Events

Alerta De Seguridad para Product name: TOYO DENGUE CASSETTE TEST KIT /// Record number: 80721060014 /// affected version (s): TDGP01 /// affected lot: DG11403 / / / Product hazard class: III.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por JC PHARMA & HEALTH COMÉRCIO, EXPORTAÇÃO E IMPORTAÇÃO LTDA-MELTD.; Turklab Tibbi Malzemeler San. TIC. A.S...

¿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
    1881
  • Fecha
    2016-05-02
  • 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
    The product is under investigation due to suspected quality deviations. And, as long as the investigation is not completed, the user should proceed with the product segregation sending Alert Message.
  • Causa
    The company describes that there is "a suspected problem associated with product malfunction, ie failure to diagnose." failure verification is still under investigation.
  • Acción
    Risk classification: III /// Classification of the field action: collection and destruction of the product, if the technical complaint is confirmed /// Field action code: TECVITRO-001/2016 /// Recommendations to users and patients: do not use the suspect model / batch and segregate the product while the suspected quality diversion is under investigation.

Device

Product name: TOYO DENGUE CASSETTE TEST KIT /// Record number: 80721060014 /// affected version (...

Manufacturer

JC PHARMA & HEALTH COMÉRCIO, EXPORTAÇÃO E IMPORTAÇÃO LTDA-MELTD.; Turklab Tibbi Malzemeler San. T...
  • Source
    ANVSANVISA