Events

Retiro De Equipo (Recall) de Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Thyroid Stimulating Hormone (TSHL) LOCI Free Thyroxine (FT4L) Thyroid Stimulating Hormone (TSH) Cardiac Troponin I (CTNI) Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)

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-01350-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-24
  • 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-01350-1
  • 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
    In march 2017, siemens healthcare issued an urgent recall for product correction vc 17-04 (tga ref: rc-2017-rn-01350-1) regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension and dimension vista assays. the ongoing investigation by siemens has identified the following new information regarding biotin interference:1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the affected assays. these concentrations of biotin can potentially result in interference >10%; and2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin can potentially result in interference >10%.Siemens is continuing to investigate biotin interference with our assays and more information will be forthcoming. the probability of misinterpretation of results due to this issue is unlikely.
  • Acción
    Siemens is advising users of the correct biotin interference levels for the affected assays. A lookback of previously generated results is not recommended.

Device

Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Th...
  • Modelo / Serial
    Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD)Thyroid Stimulating Hormone (TSHL)LOCI Free Thyroxine (FT4L)Thyroid Stimulating Hormone (TSH)Cardiac Troponin I (CTNI)Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)Multiple Catalogue Numbers and SMNs (see attached)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