Events

Retiro De Equipo (Recall) de ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. 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 Healthcare Pty Ltd.

¿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-2015-RN-00739-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-08-12
  • 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-2015-RN-00739-1
  • 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 that urea nitrogen reagent kit lots listed and urea nitrogen concentrated reagent kit lots listed for use on advia 1200, 1650, 1800, 2400 and xpt chemistry systems demonstrate an increased incidence of calibration failures. results cannot be generated by the system when calibration fails. failed calibration may lead to a slight delay in results until a replacement or suitable material to perform the calibration verification is obtained. the risk to health is negligible.
  • Acción
    Siemens is advising users that if they experience this issue, to request unaffected replacement product. Siemens is not recommending a review of previously generated results. This action has been closed-out on 07/09/2016.

Device

ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnos...
  • Modelo / Serial
    ADVIA Chemistry System – Urea Nitrogen and Urea Nitrogen Concentrated Assays. An in vitro diagnostic medical device (IVD)Urea Nitrogen AssayCatalogue Number: 03040257Lot Numbers: 321973, 333872Expiry date: 2015-11Lot Number: 348126Expiry date: 2016-06Urea Nitrogen Concentrated AssayCatalogue Number: 06860558Lot Number: 321967 Expiry date: 2015-11Lot Number: 332365 Expiry date: 2016-03ARTG Number: 176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA