Events

Alerta De Seguridad para Dengue - Rapid IgG and IgM Strip Test / Manufacturer: PanBio PTY LTD / Registration Number: 10225960019 / Registration Mat: 19/3/2006, Lot No: 04050,

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PanBio PTY LTD / Medivax Indústria e Comércio 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
    780
  • Fecha
    2004-09-14
  • 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
    Verify that you received a letter from Medivax Industria e Comércio Ltda., Identify and isolate the product Dengue - Fast IgG and IgM strip test in your inventory, and send them to Medivax under the care of the responsible technician. For more information, contact Medivax by phone at (21) 2283-2833 or your local representative. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
  • Causa
    Deviation of quality, and the product may present a false negative result.
  • Acción
    The importing company is providing to its customers the immediate withdrawal of the said product from the market due to deviations of quality.

Device

Dengue - Rapid IgG and IgM Strip Test / Manufacturer: PanBio PTY LTD / Registration Number: 10225...

Manufacturer

PanBio PTY LTD / Medivax Indústria e Comércio Ltda
  • Source
    ANVSANVISA