Events

Retiro De Equipo (Recall) de Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). 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-00151-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-15
  • 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-00151-1
  • 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 investigations have confirmed that with sysmex cs-2000i or sysmex cs-2100i systems the last (up to 4) measurements out of a thromborel s vial may be erroneously prolonged (longer pt sec, lowered % of norm, increased inr). this may occur if the reagent in the vial is nearly used up and has been placed on board of the sysmex cs-2000i/cs-2001i systems for more than 4 hours.
  • Acción
    End users are being advised to mix reagent carefully every 4 hours. Review of patient results should be carried out at the discretion of the laboratory director. Siemens representative will contact the affected customers as soon as a technical solution is available.

Device

Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determin...
  • Modelo / Serial
    Thromborel S for use with the Sysmex CS-2000i or Sysmex CS-2100i analysers (Used for the determination of prothrombin time). An in vitro diagnostic medical device (IVD)Siemens Catalogue & Material Numbers: OUHP295 / 10446442 & OUHP495 / 10446445Sysmex Japan Catalogue & Material Numbers: OUHP295J / 10469932 & OUHP495J / 10469933ARTG Numbers: 178501 & 179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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