Events

Retiro De Equipo (Recall) de Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 Series and RAPIDPoint 500 Analysers. 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-2012-RN-01168-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-11-21
  • 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-2012-RN-01168-1
  • 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
    The automatic quality control (aqc) cartridge can be difficult to remove from the system and will occasionally post a d33:2 valve error and fail to eject from the instrument. the manufacturer advises that the error is generated only during a failed ejection of the aqc cartridge. the issue appears to coincide with the recent introduction of the new return spring design for the aqc cartridge.
  • Acción
    Siemens is providing work around instructions for users to implement.

Device

Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 S...
  • Modelo / Serial
    Automatic Quality Control (AQC) Cartridge for use with the RAPIDLab 1200 Series, RAPIDPoint 400 Series and RAPIDPoint 500 Analysers. In vitro diagnostic medical device (IVD)Siemens Material Number: 10310323Serial Number: 1335866035 to 1350036305ARTG Number: 185171An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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