Events

Retiro De Equipo (Recall) de Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. 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-2014-RN-00003-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-03
  • 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-2014-RN-00003-1
  • 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 an overall average positive bias of 23% against the who 2nd irp 75/502 with the immulite systems total ige assays. the immulite total ige controls will not detect this bias. this issue is not expected to impact patient care since the observed bias in values would not impact selection for omalizumab therapy for asthma.
  • Acción
    Siemens is providing laboratories with this information to allow informed clinical decisions when undertaking Total IgE testing. There are currently no unaffected batches available in Australia. A lookback of previously generated results is a the discretion of the laboratory.

Device

Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in...
  • Modelo / Serial
    Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in vitro diagnostic medical device (IVD)Immulite/Immulite 1000 Total IgETest Code: TIECatalogue Number: LKIE1Seimens Material Number: 10380867Lot Number: 326 and aboveImmulite 2000/Immulite 2000 XPi Total IgETest Code: TIECatalogue Number: L2KIE2, L2KIE6Siemens Material Number: 10380873, 10380872Lot Number: 260 and aboveARTG Number: 179719
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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