Events

Retiro De Equipo (Recall) de Siemens Centaur Tnl Ultra

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 Inc.

¿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
    18574
  • Fecha de inicio del evento
    2015-05-22
  • 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
    Siemens healthcare diagnostics has observed a system-to-system bias between the tni-ultra™ assay on the advia centaur® cp and advia centaur/advia centaur xp/advia centaur xpt systems with the advia centaur cp generating lower results than the advia centaur/advia centaur xp/advia centaur xpt system. siemens is actively pursuing the cause of this issue., this observation impacts customers who use the tni-ultra assay on both the advia centaur cp and advia centaur/advia centaur xp/advia centaur xpt systems interchangeably when interpreting serial testing in patient samples. this communication does not impact customers who use tni-ultra results solely from either the advia centaur/advia centaur xp/advia centaur xpt system or the advia centaur cp system.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Centaur Tnl Ultra
  • Modelo / Serial
    Model: SMN: 10317708 (100 test kit), 10317709 (500 test kit), Affected: Kit Lots ending in 088, 089, 090, 091, 093 and 094 and all future lots until the issue is resolved and a follow-up communication is issued
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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