Events

Retiro De Equipo (Recall) de Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. 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 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-2012-RN-01174-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-21
  • 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-2012-RN-01174-1
  • 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
    The manufacturer confirms a positive shift in patient medians of approximately 20% with the igf-1 assay. the manufacturer advises that the performance of kit lots currently in distribution is in alignment with the medians of the reference data range published in instructions for use. additionally, siemens wants to notify customers of an upcoming major supply disruption.
  • Acción
    Laboratories to implement the work-around provided by the sponsor. A review of previously reported results should be considered.

Device

Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagn...
  • Modelo / Serial
    Immulite / Immulite 1000 XPi IGF-1 and Immulite 2000 / Immulite 2000 XPi IGF-1. An in vitro diagnostic medical device (IVD)Immulite / Immulite 1000 XPi IGF-1Catalogue Number: L2KGFSiemens Material Number: 10381448Lot Number: 441-492Immulite 2000 / Immulite 2000 XPi IGF-1Catalogue Number: LKGF1Siemens Material Number: 10381403Lot Number: 315-334ARTG Number: 179720
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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