Events

Rappel de Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation 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-00843-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-29
  • 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-00843-1
  • 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 healthcare diagnostics has confirmed a carry-over risk on sysmex cs systems due to the applications using ca-clean i (964-0631-3) for sample probe rinse. under certain circumstances, the carry-over might impact results for factor v with innovin, factor xii with dade actin fsl, berichrom f xiii, innovance d-dimer assays. in case of innovance d-dimer, only frozen samples are concerned by a potential carry-over. no impact by carry-over was observed with innovance d-dimer when using fresh normal plasma or control plasma.
  • Action
    Siemens Healthcare Diagnostics is advising the user to run all affected above mentioned test applications (Protein C with Protein C Reagent, Protein S with Protein S Ac Reagent and Factor V Leiden with ProC Global Reagent) together in a “Batch Mode” and perform an extra prime and rinse step at the end of the batch. Siemens Healthcare Diagnostics is working on a solution to fix the issue and will communicate when a solution is available. Siemens does not recommend a look back of previously generated results since the coagulation status changes over the time, and does recommend that this communication is reviewed with the laboratory medical director.

Device

Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic me...
  • Modèle / numéro de série
    Sysmex CS-2000i/CS-2100i/CS-5100 Automated blood coagulation analysers. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 10488064, 10488062, 10709128Affected Applications: Protein C with Protein C Reagent (OQYG11), Protein S with Protein S Ac Reagent (OPAP03) and Factor V Leiden with ProC Global Reagent (OQLS13)ARTG number:179939
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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