Events

Rappel de Sysmex CS-2000i and CS-2100i systems (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 Healthcare Pty Ltd.

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-2016-RN-01073-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-22
  • 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-2016-RN-01073-1
  • 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
    There is the potential for mismatched sample id's under a rare circumstance where the host computer connected to the instrument sends a measurement order irregularly to the instrument. the host computer displays a 'time out' error and when measuring the next sample displays the error 'host computer order is wrong' and overwrites the previous sample id with the current sample being measured. there is the potential for a mis-diagnosis as a result of the error, however there have been no reported injuries as a result of the issue.
  • Action
    Siemens is advising users to repeat the measurement of all samples in an affected sample rack when the instrument displays the error 'HC Order is wrong". A look-back at patient results is at the discretion of the laboratory director. If the error occurs, users should contact the Host Computer Vendor to confirm the interface protocol is running correctly.

Device

Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnos...
  • Modèle / numéro de série
    Sysmex CS-2000i and CS-2100i systems (Automated blood coagulation analysers). An in vitro diagnostic medical device (IVD)Siemens Material Number : 10488064, 10488062All software versionsARTG Number:179939
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA