Events

Alerta De Seguridad para AxSYM FSH Master Calibrator lot 33266Q100 - Reg. No. 10055311046

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

¿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
    861
  • Fecha
    2007-01-25
  • 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 Controls are not expected to be outside the range established by the Bull. however, if the laboratory defines its own reference value, it is possible to obtain values ​​outside the established range. If you have any questions about the information contained in this release, please contact the Customer Service Center. 0800-119099 - Abbott Laboratorios do Brasil Ltda
  • Causa
    Deviation up the results by around 9 - 14%, with a total predictive value up to 18 to 22%.
  • Acción
    Abbott conducted internal investigation which determined an atypical stability profile for batches 33266Q100 of the AxSYM FSH Master Calibrator and batch 333662Q100 of the AxSYM FSH Master Calibrator while simultaneously causing a shift in patient and control outcomes. The company recommends that you discontinue use of batches 33266Q100, store and return to Abbott Laboratories.

Device

AxSYM FSH Master Calibrator lot 33266Q100 - Reg. No. 10055311046

Manufacturer

Abbott Laboratórios
  • Source
    ANVSANVISA