Alerta De Seguridad O Notificaciones De Seguridad para ADVIA Centaur and ADVIA Centaur XP

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Siemens Healthcare Diagnostics Inc.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
  • Número del evento
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
  • Causa
    A failure of the wash interconnect circuit board on the advia centaur and advia centaur xp analysers may produce the following errors: 1. failure to detect that the ‘wash 1’ bottle is empty. this could result in credible but erroneous results reported on a number of tests. see affected assays listed below. or 2. incorrect indication that the ‘wash 1’ bottle is empty when actually full, causing the system to stop processing samples. siemens is planning software and hardware updates to resolve these issues by the end of march 2013. the table below summarises the assays affected and what the potential effect is for each. assay type assay potential effect on assay results auto-immune ana false positive or negative bone vitd false positive or negative cardiovascular bnp, high bias ddimer, false positive or negative tniultra always elevated torch and special id rubg2, false positive or negative rubm, false positive or negative toxg, false positive toxm false positive reproductive endocrinology dheas, false positive or negative ee2, false positive or negative shbg false positive or negative infectious disease ahavm, false positive ahavt/havt, low bias ahbcm, false negative ahbct/hbct, false negative ahbe, high or low bias ahbs, false positive ahbs, false positive ahbs2, false positive or negative ahcv, false positive or negative chiv, false positive or negative cmvg, false positive or negative conf, false positive or negative ehiv, false positive hbeag, false positive hbs, false positive hiv, false positive or negative pct, false positive or negative syph false positive or negative immunosuppressant csa low bias liver fibrosis ha,  false positive or negative piinp, false positive or negative timp1 false positive or negative tumour markers / oncology ca153, false positive ca19-9, false positive ca199a, false positive or negative freepsa false positive or negative thyroid tsh3ul false positive or negative.
  • Acción
    Identify if you have affected devices. Follow the manufacturer’s recommendations in the FSN to: Monitor ‘Wash 1’ fluid levels manually. Replace the ‘Wash 1’ bottle before the fluid is depleted. Clear incorrect status or error messages that prohibit testing. Contrary to the manufacturer’s FSN, consider the need to review previous results.


  • Modelo / Serial
  • Descripción del producto
    Laboratory analysers for a variety of tests including HIV, tumour markers and hepatitis. Specific assays. Laboratory analysers: ADVIA Centaur ® and ADVIA Centaur ® XP. Specific catalogue numbers. The following assay systems are affected by this alert: ADVIA Centaur system (Cat. 078-A001-xx) ADVIA Centaur refurbished (Cat. 078-A002R02) ADVIA Centaur XP system (Cat. 078-A011-03) ADVIA Centaur XP refurbished (Cat 078-A011R03)
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source