Events

Alerta De Seguridad para ADVIA 1200 Chemistry System; ADVIA 1650 Chemistry System; ADVIA 1800 CHEMISTRY SYSTEM; ADVIA 2400 Chemistry System .. Registro Anvisa: 10345160456; 10345160453; 10345160636; 10345160471, respectively.

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 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
    1341
  • Fecha
    2001-12-17
  • 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 Healthcare Diagnostics is conducting corrective field action for the ADVIA 1200, ADVIA 1650, ADVIA 1800 and ADVIA 2400 Chemistry Systems run with software versions V2.00, V2.01; V3.52, V4.01; V2.01; V4.01 respectively. These versions may display AutoCalibration with system-related errors ("s", "t", "S", "r", "F", "A", "M", "Q", or "G"). autocalibration with batch change without error message display and Mid-Calibration Reagent Exchange or Mid-QC generating a calibration curve with a combination of main reagent data and Backup.
  • Causa
    These versions may display autocalibration with system-related errors ("s", "t", "s", "r", "f", "a", "m", "q", or "g").
  • Acción
    Corrective field action for ADVIA 1200, ADVIA 1650, ADVIA 1800 and ADVIA 2400 Chemistry Systems run with software versions V2.00, V2.01; V3.52, V4.01; V2.01; V4.01 respectively.

Device

ADVIA 1200 Chemistry System; ADVIA 1650 Chemistry System; ADVIA 1800 CHEMISTRY SYSTEM; ADVIA 2400...

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA