Events

Retiro De Equipo (Recall) de Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. 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-2016-RN-01555-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-30
  • 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-01555-1
  • 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 immulite 2000 / immulite 2000 xpi intact pth kit lot 320 can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml (<2.1 pmol/l) with serum and edta patient samples vs. a reference kit lot. for ipth concentrations of 20 to <50 pg/ml (2.1 to <5.3 pmol/l) the average bias was - 22%, for 50 to <100 pg.Ml (5.3 to <10.5 pmol/l) it was -18% and for =100 pg/ml ( =10.5 pmol/l) it was -5%. depending upon the quality control ranges used by your laboratory, this issue may not be detected by quality controls. when this issue occurs, the potential exists for misinterpretation of ipth levels which may delay determination of the etiology of hypercalcemia or hypocalcemia. clinical impact would be mitigated by correlation to clinical symptomology and additional diagnostic laboratory testing.
  • Acción
    Users are advised to discontinue use of and discard Immulite 2000/Immulite 2000 XPi Intact PTH kit lot 320. Affected product will be replaced by Siemens. The review of previously generated results is at the discretion of the laboratory.

Device

Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic...
  • Modelo / Serial
    Immulite 2000 / Immulite 2000 XPi Intact Parathyroid Hormone (iPTH) assay. An in vitro diagnostic medical device (IVD).Test Code: iPTHCatalogue Numbers: L2KPP2, L2KPP6Siemens Material Numbers: 10381441, 10381442Lot Number: 320Expiry: 30 Nov 2016ARTG Number: 179720
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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