Events

Retiro De Equipo (Recall) de ADVIA Centaur Cleaning Solution. 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
    Recall
  • ID del evento
    RC-2014-RN-00999-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-09-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00999-1
  • 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 confirmed the advia centaur systems cleaning solution, lots 459356 and 443105, has degraded at a higher than expected rate. siemens have confirmed that there is sufficient concentration of sodium hypochlorite to ensure effective instrument cleaning at this time.
  • Acción
    Siemens is advising their customers to discontinue use of and discard the affected kit lots. This action has been closed-out on 26/02/2016.

Device

ADVIA Centaur Cleaning Solution. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    ADVIA Centaur Cleaning Solution. An in vitro diagnostic medical device (IVD).Catalogue Number: 112748Lot Numbers: 459356, 443105Expiration Date: November 2014ARTG Number: 174700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA