Events

Retiro De Equipo (Recall) de PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)

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 Ltd Diagnostics Division.

¿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-2013-RN-00648-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-28
  • 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-2013-RN-00648-1
  • 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 has confirmed an overall average positive bias of approximately 20%-23% across the assay range relative to who 96/670 with the immulite systems psa assays. this positive bias is observed in patient values and the siemens tumor marker controls (tmco).
  • Acción
    Siemens are advising users to discontinue use and discard any remaining kits. Replacement kits will be available in July 2013. Siemens is recommending a lookback period of two months of previous test results. For results that were recorded as abnormal, please notify the treating physician. Actions by the clinician may be to reconsider a scheduled biopsy based on the test result taking into account the other factors that made biopsy a consideration.

Device

PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an ...
  • Modelo / Serial
    PSA Assays for use on Immulite, Immulite 1000, Immulite 2000 and Immulite 2000 XPi analysers (an in vitro diagnostic medical device)Multiple Lot numbers affectedMultiple Catalogue numbers affectedAll kit lots released in February 2012.ARTG Number: 180971
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA