Events

Retiro De Equipo (Recall) de Siemens Sysmex CS-2000i/2100i Systems with Thomborel S

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare Diagnostics Products GmbH.

¿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
    14221
  • Fecha de inicio del evento
    2013-02-15
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer has confirmed that with sysmex cs-2000i and 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-2100i systems for more than 4 hours.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Sysmex CS-2000i/2100i Systems with Thomborel S

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA