Events

Alerta De Seguridad para ADVIA Centaur HIV 1/0/2 Enhanced (EHIV), registry: 10345161854, risk class IV; series: 44563141; 4,550,2141; 47542143; 4,844,414; 5,146,245; 52901147.

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
    1592
  • Fecha
    2015-05-22
  • 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
    According to the manufacturer, the probability of reporting an erroneous result (reactive or non-reactive) is unlikely, as this can be detected by quality control. The results of patients obtained with this assay are acceptable if they are followed by valid quality control results.
  • Causa
    Product quality control results out of the expected range. the registry subject relates the issue to the decrease in onboard stability of the ehiv assay reagent.
  • Acción
    The company will perform an update / correction of the instructions for use. Guidance is that if quality control results are not out of the expected ranges, no action is required. If quality control results are obtained outside the expected range, it is recommended that: a. Recalibrate the test every 7 days; B. Replace the reagent cartridge every 14 days. MORE INFORMATION IN THE LETTER TO THE CLIENT ATTACHED

Device

ADVIA Centaur HIV 1/0/2 Enhanced (EHIV), registry: 10345161854, risk class IV; series: 44563141; ...

Manufacturer

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