Events

Alerta De Seguridad para In Vitro Diagnostic Kit ADVIA CENTAUR PRGE, Hazard Class II, Record: 10345160327. Serial numbers: 42564268; 4,262,128; 4,383,326; 4,2565,268; 42624268; 4,343,826; 4,2590,268; 4,374,228; 44847268.

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 Ltda.; 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
    1532
  • Fecha
    2015-02-26
  • 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
    Samples with values ​​lower than 30ng / mL did not demonstrate bias.
  • Causa
    Confirmed the presence of positive bias when the sample results are higher than 30ng / ml when compared to master curve in the use of the advia centaur progesterone kit.
  • Acción
    The company advises that the use of the progesterone kit should not be discontinued. In samples with a result higher than 30ng / mL, they should be diluted and there is no special action for results lower than that. Check instructions for how to edit the test linearity checkpoint in the ADVIA Centaur Operator's Manual to indicate that the sample should be diluted. The company asks clients to complete the Effective Field Action Verification Form (APPENDIX).

Device

In Vitro Diagnostic Kit ADVIA CENTAUR PRGE, Hazard Class II, Record: 10345160327. Serial numbers:...

Manufacturer

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