Events

Rappel de Freelite Human Kappa Integra Kit. 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 In Vitro Technologies 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-00231-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-04
  • 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-00231-1
  • 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 has determined that the affected calibrator and controls require a reassignment which is 16% lower than the value established during the manufacture of this product. in vitro technologies is advising users to recalibrate the affected lots with the new calibrator values provided. the assay bias of 16% would result in a minimal change to low values. however the difference would be proportionately greater at higher values.
  • Action
    In Vitro Technologies is providing users with revised target and range values to be used with the affected kits. The Director of Chemical Pathology should be consulted to determine the need for a review of results previously reported using this kit

Device

Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)Item Numbers: TBSLK01610RI and TBSLK016ILot Numbers: 354992, 355769ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd