Events

Retiro De Equipo (Recall) de ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dimension Vista LOCI Progesterone; Assay: Immulite/Immulite 1000 Progesterone; Assay: Immulite 2000 Progesterone

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-00039-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-01-10
  • 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-00039-1
  • 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 presence of dhea-s (a metabolite of dhea, a steroid hormone that may be used as part of in vitro fertilisation (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results on certain platforms around the clinically important decision level of approximately 1 ng/ml (3.18 nmol/l) of progesterone. this threshold is used by some ivf protocols to determine whether to proceed with fresh embryo transfer in the current cycle.
  • Acción
    Affected assays should not be used to report results for patients who are taking DHEA supplements. For patients taking DHEA supplements, an alternate method such as Liquid Chromatography-Mass Spectroscopy (LCMS) which is not expected to show cross reactivity to DHEA-S should be used to measure progesterone concentrations. Siemens’ Progesterone assays may continue to be used to report results for patients who are not taking DHEA supplements. A review of previously generated results is at the discretion of the laboratory.

Device

ADVIA Centaur, Dimension Vista & Immulite Systems - Assay: ADVIA Centaur Progesterone; Assay: Dim...
  • Modelo / Serial
    ADVIA Centaur, Dimension Vista & Immulite SystemsAssay: ADVIA Centaur ProgesteroneTest Code: PRGECatalogue/SMN # 10310305, 10315522, 10333111Assay: Dimension Vista LOCI ProgesteroneTest Code: PROGCatalogue: K6464SMN: 10461743Assay: Immulite/Immulite 1000 ProgesteroneTest Code: PRGCatalogue: LKPW1SMN: 10381128Assay: Immulite 2000 ProgesteroneTest Code: PRGCatalogue: L2KPW2, L2KPW6SMNs: 10381181, 10381170All LotsARTG # 175698, 180109, 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