Events

Retiro De Equipo (Recall) de ADVIA Centaur TnI-Ultra

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-2015-RN-00442-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-25
  • 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-2015-RN-00442-1
  • 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 healthcare diagnostics has observed a system-to-system bias between the tni-ultra assay on the following systems:- advia centaur cp and - advia centaur- advia centaur xp- advia centaur xpt the advia centaur cp is generating lower results than the advia centaur/advia centaurxp/advia centaur xpt system. siemens is actively pursuing the cause of this issue.
  • Acción
    Siemens is providing end users with information to assist with the interpretation and release of troponin results. Siemens internal investigation has confirmed the clinical utility of the assay at the 99th percentile for healthy individuals (0.02 - 0.06 ng/mL (µg/L)) is not impacted by this issue.

Device

ADVIA Centaur TnI-Ultra
  • Modelo / Serial
    ADVIA Centaur TnI-UltraSiemens Material Numbers: 10317708 and 10317709Lots numbers ending in 088, 089, 090, 091, 093 and 094 and all future lots until issue is resolvedARTG number: 175197An 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