Alerta De Seguridad para Biocheck Strip Bioeasy. Anvisa Registration Number 10374660079. Class of risk - Class IIIa

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bioeasy Diagnóstica 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
    892
  • Fecha
    2007-05-29
  • País del evento
  • Fuente del evento
    ANVISA
  • 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 carried out the replacement of some units of lot TD07A230-B03 after receiving a health service notification regarding the divergence of information between the code number and CODE number. The notification was also forwarded to ANVISA, through NOTIVISA, with the error identified: - CODE 1409 in the primary packaging and in the code strip 1973; - CODE 1409 in the primary packaging and the code strip 1410. After being questioned by Anvisa, the company informed that there was a failure in the packaging system, which enabled a Chip Code package with 12 units to be released with a different identifier number of the product packaging. According to the company, the imported quantity of this lot was 350 boxes, all of them being sold with a single distributor.
  • Causa
    Inconsistent with the code information of the primary packaging and the strip-code.
  • Acción
    Bioeasy Diagnostica Ltda reported that the problem was isolated and restricted to only one customer. Units with bypass have been replaced.

Manufacturer

  • Source
    ANVSANVISA