Events

Rappel de Total IgE for use with Immulite, Immulite 1000, Immulite 2000, Immulite 2000 XPi analysers. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00003-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00003-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA