Events

Retiro De Equipo (Recall) de ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays

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-00068-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-15
  • 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-00068-1
  • 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 is conducting a correction for the certain estradiol products. it has been confirmed that the drug fulvestrant (faslodex) may cause falsely elevated estradiol results in the assays listed, which could lead the clinician to misinterpret the patient as pre-menopausal possibly leading to altered or discontinued use of the potential beneficial drug fulvestrant.The risk to health applies to all patients being treated with the drug fulvestrant.
  • Acción
    Siemens’ Estradiol assays may continue to be used to report results for patients not on Fulvestrant therapy; these assays should not be used for patients being treated with Fulvestrant. For patients being treated with Fulvestrant, an alternate method such as LC-MS which is not expected to show cross reactivity to Fulvestrant should be used to measure Estradiol concentrations.

Device

ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol Assays
  • Modelo / Serial
    ADVIA Centaur Systems, Dimension Vista Systems & IMMULITE Systems Estradiol AssaysADVIA Centaur Enhanced EstradiolCatalogue # and SMN: 10490889, 10491445, 10697757Dimension Vista LOCI EstradiolCat # K6463SMN: 10489099IMMULITE/ IMMULITE 1000 EstradiolCat #: LKE21, LKE21(D)SMN: 10381132, 10702832IMMULITE 2000 EstradiolCat #: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D)SMN:10381178, 10702833, 10381177, 10702834All lots affectedARTG # 175698, 180109 and 179720
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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