Events

Alerta De Seguridad para VIDAS ESTRADIOL II - ANVISA Register n ° 10158120172 - Lot: 8118666001. Reference: 30431

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOMÉRIEUX 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
    883
  • Fecha
    2007-08-20
  • 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 company informs that until this date they have not received any complaints from the customers who purchased the product. It also informs that if the value of control C1 is outside the expected reading values, the results can not be validated. Anvisa will follow up on 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.
  • Causa
    Rfv reading (relative fluorescence value) of the kit's internal control (c1), outside of the acceptance criteria.
  • Acción
    The company decided to block the commercialization of the lot and inform the customers of the collection of the lot involved.

Device

VIDAS ESTRADIOL II - ANVISA Register n ° 10158120172 - Lot: 8118666001. Reference: 30431

Manufacturer

BIOMÉRIEUX S.A.
  • Source
    ANVSANVISA