Events

Alerta De Seguridad para SLIDEX MENINGITE KIT 5 - ANVISA Registration nº 10158120198, Expiration of Registration: 19/12/2011, LOT NO .: 804114501, valid for lot: 12/21/2006.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomérieux Brasil S/A.

¿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
    843
  • Fecha
    2006-11-27
  • 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
    According to company information following the investigations and risk analysis, they concluded that the health impact is extremely low, as the etiological diagnosis of bacterial meningitis is based on a set of diagnostic tests and clinical evaluation. The symptoms are usually accompanied by antibiotic therapy. The Unit of Technovigilance - UTVIG / NUVIG / ANVISA is monitoring the actions of the company. ////////// In a letter dated December 20, 2006, the Company informs the closure of voluntary collection.
  • Causa
    Reports, 04 complaints, being 01 in brazil, of loss of sensitivity gradient of reagent r5 (antimenigiccic type c) against r6 (positive control), and eventual release of false negative results may occur.
  • Acción
    The company informs the blocking and the commercialization of the lot, and communicates to its customers by means of collection letter of the lot 804114501.

Device

SLIDEX MENINGITE KIT 5 - ANVISA Registration nº 10158120198, Expiration of Registration: 19/12/20...

Manufacturer

Biomérieux Brasil S/A
  • Source
    ANVSANVISA