Events

Rappel de Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (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-2015-RN-00520-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-17
  • 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-2015-RN-00520-1
  • 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
    The conductive material of the sample cup holders and microsample inserts, which are used to process samples, do not meet specification for facilitating sample level sensing. when sample level sensing is compromised, sample will not be pipetted and the test or tests ordered for the sample will not be run.
  • Action
    This issue has been corrected for future lots of sample cup holders and microsample inserts. Siemens is requesting laboratories to cease using the faulty sample cup holders and microsample inserts until unaffected sample receptacles are received.

Device

Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical ...
  • Modèle / numéro de série
    Immulite (all systems) - Sample Cup Holders and Microsample Inserts. In vitro diagnostic medical devices (IVD)Sample Cup Holder used on Immulite/Immulite 1000 SystemsSiemens Material Number: 10385360 (Set 1-50)Lot number: 15, 16Microsample Insert used on Immulite 2000 / 2000 Xpi SystemsSiemens Material Number: 10385209 (Set of 15)Lot number: 18, 19, 20ARTG Number: 174399
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA