Events

Rappel de Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. 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 Zoll Medical Australia 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-2013-RN-01364-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-12-24
  • 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-2013-RN-01364-1
  • 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 manufacturer, itc has determined that citrate aptt cuvettes from the lots listed above may recover higher than expected results in normal individuals. itc’s investigation into the affected lots identified that when performing tests on non-heparinized e.G., normal blood samples, results may average higher than historic values. test results performed on patients receiving heparin therapy are not affected. itc has evaluated the risk to health using the affected device and has determined under a variety of clinical conditions, an erroneous increase in the citrated aptt baseline may contribute to serious injury.
  • Action
    Zoll Medical Australia is requesting their customers to inspect their stock and quarantine all affected lots of the product. Zoll Medical Australia will arrange for the recovery and replacement of stock. Customers are advised that the requirement for retesting reported patient results should be discussed with the Laboratory Director.

Device

Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes. An in vitro diagnostic medical dev...

Manufacturer

Zoll Medical Australia Pty Ltd