Events

Retiro De Equipo (Recall) de ADVIA Chemistry Systems. 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-2013-RN-01158-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-11
  • 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-2013-RN-01158-1
  • 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
    When the system switches from the primary reagent pack to the back-up reagent pack, the software may result in the auto-calibration or qc to utilise the incorrect values for the blank and standard. the systems should not pass calibration and qc, however, the software version affected may allow the system to pass calibration and qc. this may result in a shift in patient results which can be observed through patient trending.
  • Acción
    A software upgrade will be implemented for ADVIA systems 1800 and 2400 as a permanent fix. As the ADVIA 1650 is planned to be made obsolete effective March 2014 the software update has not been designed for this device. Siemens is providing users with work around instructions to follow as an interim measure. A review of previously generated results is at the discretion of the laboratory director. Thia action has been closed on 28/01/2016

Device

ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Chemistry Systems. An in vitro diagnostic medical device (IVD)ADVIA 1650Software versions: V3.52, V4.01ADVIA 1800Software version: V2.01ADVIA 2400Software version: V4.01Siemens Reference Number: CHSW 13-03ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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