Events

Alerta De Seguridad para Trade name: Dimension Amonia Flex Technical name: AMÔNIA Registration number ANVISA: 10345161934 Hazard class: II Affected model: 120 tests Serial numbers affected: FB7152; BA7250

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC.

¿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
    2074
  • Fecha
    2017-01-12
  • 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
    Siemens recommends the discontinuation and disposal of the batches mentioned and subsequent replacement request. The company does not recommend retrospective analysis of previously reported results.
  • Causa
    Siemens healthcare diagnostics has determined that the dimension fb7152, eb7180, ba7194, ea7223, and ba7250 ammonia (amm) reagent lots are not maintaining the required 60 day calibration interval due to reagent instability and may also display the abnormal assay message in the results. these batches may show precise changes in results obtained for both patients and quality controls, leading to more frequent recalibrations than the 60-day period indicated in the instructions for use (ifu) of this reagent.
  • Acción
    Field Action DC Code 17-01 released under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: Dimension Amonia Flex Technical name: AMÔNIA Registration number ANVISA: 10345161934 ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA