Events

Alerta De Seguridad para ADVIA CENTAUR HBsAgII (HBsII), Registration 10345161861, Lot 56167056

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
    1692
  • Fecha
    2015-09-21
  • 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 has identified that an "Invalid" result from positive quality control delays the release of positive samples from patients during the confirmatory test.
  • Causa
    Siemens healthcare diagnostics has identified an error on the advia centaur confirmation card which is included in the advia centaur hbsagii kit. the error is interpreted as "invalid" and a "conf n / a" flag appears when the positive control of hbsagii is tested in the confirmatory assay hbsagii.
  • Acción
    The company informs that lot 56167056 of ADVIA Centaur / ADVIA Centaur XP and ADVIA Centaur XPT can be used to generate HBsAgII assay results, however, an alternative lot or method should be used if there is a need to report positive results using the assay ADVIA Centaur conf.

Device

ADVIA CENTAUR HBsAgII (HBsII), Registration 10345161861, Lot 56167056

Manufacturer

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