Events

Retiro De Equipo (Recall) de ADVIA 1200, 1650, 1800 and 2400 Clinical 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-00933-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-09-05
  • 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-2013-RN-00933-1
  • 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 has confirmed that the affected advia chemistry systems will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. in cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. if a numerical result is generated with a flag, the ratio will be reported without a flag.
  • Acción
    End users are requested to ensure that all ratio tests should be reviewed for flags prior to approving. Siemen's is developing a new version of software that will introduce a new flag for all ratio results that have a flag on a component test.

Device

ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device...
  • Modelo / Serial
    ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)Siemens Reference Number: CHSW 13-01ARTG Number: 174383
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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