Alerta De Seguridad para BIOELISA NEUROCISTI - Registration No. 10158120055, Lots B60521 - Validity May 29, 2007 E 6021 - Validity May 29, 2007

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOMERIEUX BRASIL.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 company informs that the product Bioelisaneurociste has as principle the use of samples of Cefalorraquidiano liquid (CSF), which are incubated with antigenic components of Cysticercus cellulose previously fixed to the cavity of plastic plates. The antigen-antibody complex is evidenced by anti-IgG enamel conjugate and chromogenic solution. The intensity of the developed color is evaluated by spectrophotometric reading. It also states that all the results of the analysis of the product, carried out at the time of release of the batch for commercialization, were in accordance with the criteria established in IT / CQ / 097 (Quality Control Technique - Blioelisaneurociste - R1 to R9). ///// If you have in your stock the lots mentioned, contact your local representative or manufacturer by means of the telephone 0800.264 848 - option 2 ///// Anvisa through the Unit of Technovigilância will be following the case , in order to ensure that health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product. On September 27, 2007, the Company presented the UTVIG, a copy of the certificate of destruction of the kits collected in the market.
  • Causa
    Fall of od (optical density) values ​​of positive control sera. this is below that specified in the package insert, invalidating the test.
  • Acción
    The Company informs by: Recall of the specified lots; Block the sale of said lots; Information to customers to collect lots involved


  • Source