Events

Retiro De Equipo (Recall) de Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid Stimulating Hormone

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
    21294
  • Fecha de inicio del evento
    2017-10-24
  • 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
    Update 23 october 2017 to march 2017 urgent recall for product correction regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension® and dimension vista® assays. ongoing investigation has identified the following new information regarding biotin interference:, 1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the following assays: dimension tshl, dimension ft4l and dimension vista tsh. concentrations of biotin above the concentration listed in table 2 in the revised biotin non-interference column can potentially result in interference >10%., 2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin above the concentration in the revised biotin non-interference column can potentially result in interference >10%.
  • Acción
    Manufacturer to issue advice regarding use

Device

Dimension EXL Troponin I & Dimension Vista Digoxin, Estradiol, Ferritin, Prolactin and Thyroid St...
  • Modelo / Serial
    Model: Thyroid Stimulating Hormone (TSHL), LOCI Free Thyroxine (FT4L), Thyroid Stimulating Hormone (TSH), Cardiac Troponin I (CTNI), Mass creatine kinase MB isoenzyme (MMB), Sirolimus (SIRO), All lots (including all future lots until Instructions For Use update), Affected: DM Troponin I (TNI), DV Digoxin (DIGXN), DV Estradiol (E2), DV Ferritin (FERR), DV Prolactin (PRL), DV Thyroid Stimulating Hormone (TSH) All lots including all future lots until instructions of use is updated
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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