Events

Retiro De Equipo (Recall) de ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. 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-2015-RN-00111-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-02-10
  • 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-00111-1
  • 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 determined through an internal investigation that some assays do not align with the representative data published in the instructions for use (ifu) for on-board stability, calibration frequency, and/or interference.
  • Acción
    Siemens is requesting their customers to verify that the current IFU version for methods in use in the laboratory is being followed. Navigate to the Siemens Document Library for the current version of the IFU: https://www.healthcare.siemens.com/doclib. For on-board stability and calibration frequency changes, ensure that the ADVIA Chemistry system is programmed to reflect the changes indicated in the IFU. This action has been closed-out on 03/08/2016.

Device

ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical ...
  • Modelo / Serial
    ADVIA Chemistry 1800 and 2400 Instructions For Use (IFU) Updates. An in vitro diagnostic medical device (IVD)Multiple Siemens material numbersARTG number: 175890
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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