Events

Retiro De Equipo (Recall) de ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready

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-00608-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-06-05
  • 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-00608-1
  • 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
    Manufacturer confirms that the solid phase reagent in some of the advia centaur tni-ultra readypacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
  • Acción
    Siemens is providing work around instructions to users. Only one TNI-Ultra ReadyPack is to be used on a system at one time. Patient results produced by the assay are acceptable if they follow acceptable calibration with valid quality control results. Kit lots ending in 086 or higher do not require calibration of each ReadyPack, refer IFU for the calibration interval. This action has been closed-out on 11/04/2016.

Device

ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra Ready
  • Modelo / Serial
    ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP - Troponin Ultra ReadyPack. An in vitro diagnostic medical device (IVD).Catalogue Numbers: 02789602 (100 tests) and 02790309 (500 tests)Lot Numbers:Kit Lots ending in 078Expiration: 18 July, 2014Kit Lots ending in 079Expiration: 18 July 2014Kit Lots ending in 082Expiration: 27 September, 2014Kit Lots ending in 083Expiration: 29 November, 2014Kit Lots ending in 084Expiration: 28 December 2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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