Events

Rappel de BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic 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-00025-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-08
  • 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-00025-2
  • 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 observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur. these false short clotting times were observed with turbid, haemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these rare samples showed a pre-peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by the existing check algorithms.There is a potential to miss a prolonged prothrombin time which could lead to a delay of intervention and a risk of a significant bleed.
  • Action
    Siemens is advising users check the inference levels given in the respective Application Sheets of the BCS and BCS XP systems, as such an effect can occur in turbid, haemolytic or icteric samples from intensive care patients. Siemens will provide a software upgrade which can identify irregular reaction curves in the near future. This action has been closed-out on 27/01/2017.

Device

BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic devic...
  • Modèle / numéro de série
    BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD)BCSSiemens Material Number (SMN):10454728, 10454729, 10454742, 10459303,10460659, 10461881 BCS XPSMN: 10459330, 10462449, 10461894, 10470625 Dade InnovinSMN: 10284500, 10445704, 10445705, 10445706, 10465673, 10465674ARTG Numbers: 178116 & 178501
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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