Retiro De Equipo (Recall) de ADVIA Centaur and ADVIA Centaur XP (An in vitro diagnostic medical device (IVD))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has identified an issue that on some systems a slight cracking of the tubing (the tubing for the wash 1, acid, and base bottle reservoirs) at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. the cracking may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. the potential for minimal fluid leakage outside the system exists. the drip will cause the reservoir to empty faster than the system expects. once the acid and base fluids are depleted, the system detects it and will flag all subsequent results with a signal error flag, once the lack of acid/base solution is detected. when wash 1 fluid becomes low, the system will detect it and stop processing samples. in this case, a limited number of test results (up to 20 tests) processed prior to a signal error may be affected and not flagged.
  • Acción
    Siemens is advising the customers to examine their system to see if there is any fluid in the reservoir drip tray. If fluid is present, the customer is advised to contact their Siemens Customer Care Center or local Siemens technical support representative to schedule a visit. Until a service engineer has inspected their system for this issue, Siemens recommends that the customers replace the bulk bottle for all fluids immediately when the yellow warning appears. This will help mitigate the possibility of improper fluid dispenses. Siemens service engineers will inspect the tubing on the next service visit and replace the tubing if necessary. This action has been closed-out on 11/08/2016.


  • Modelo / Serial
    ADVIA Centaur and ADVIA Centaur XP (An in vitro diagnostic medical device (IVD))Multiple Catalogue NumbersBulk Fluid Reserve Assembly (Acid & Base)Siemens Material Numbers: 10282187 & 10483525Wash 1 Reservoir ConnectorSiemens Material Numbers: 10364516 & 10483526ARTG Number: 175890
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source