Events

Retiro De Equipo (Recall) de Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Prolactin (PRL) & Thyroid Stimulating Hormone (TSH) assays. 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 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-2017-RN-00458-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-11
  • 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-2017-RN-00458-1
  • 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 has confirmed that the concentrations for biotin listed in the non-interfering substances section of the current dimension and dimension vista instructions for use (ifu) for dimension tni, dimension vista digxn, e2, ferr, prl, tsh have incorrect units, and incorrectly state the level at which biotin does not interfere. in the cases of tni, e2, ferr, prl, and tsh, there is significant interference at the levels incorrectly stated in the current ifu. dimension vista e2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays) exhibit a negative bias. digxn si units for biotin are incorrect by a factor of 100 lower than the level at which biotin does not interfere, in the current ifu.The probability of misinterpretation of results is remote, and would be limited to when a patient taking biotin supplements in excess of the daily recommended allowance has a blood sample drawn before biotin is cleared to a level that does not interfere with testing.
  • Acción
    Siemens is advising users of the correct biotin interference levels for the affected assays. This information should be reviewed with the laboratory Medical Director. In future, Siemens will be updating the IFU with the correct levels.

Device

Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Pr...
  • Modelo / Serial
    Dimension Troponin 1 (TNI) & Dimension Vista Digoxin (DIGXN), Estradiol (E2), Ferritin (FERR), Prolactin (PRL) & Thyroid Stimulating Hormone (TSH) assays. An in vitro diagnostic medical device (IVD).Multiple Catalogue and Siemens Material Numbers (SMN)All Lots (including all future lots until the IFU is updated)ARTG Numbers: 182774, 182220, 180109, 181687
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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