Events

Retiro De Equipo (Recall) de TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD) Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP

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 Healthcare Pty Ltd.

¿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-2016-RN-00603-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-12
  • 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-2016-RN-00603-1
  • 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 laboratory diagnostics has confirmed that all in date lots of advia centaur tni-ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). the instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin demonstrate = 10% change in results. the biotin level in a general population is approximately 0.3 to 1.0 ng/ml (1.2 to 4.3 nmol/l).The biotin interference is proportionate across tni concentrations; therefore, the ability of the assay to detect serial increases or decreases of tni is maintained.
  • Acción
    Siemens is advising users that the Tnl-Ultra assay can continue to be used, however, users should be aware that patients who are taking biotin supplements may exhibit a slightly elevated TnI-Ultra result; however, the ability of the assay to detect serial increases or decreases of TnI is maintained. A review of previously generated results is at the discretion of the Laboratory Director.

Device

TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An...
  • Modelo / Serial
    TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD)Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP Catalogue Numbers: 02789602, 02790309Siemens Material Numbers (SMN): 10317708, 10317709Multiple Lot Numbers affectedARTG Number: 175197
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA