Events

Rappel de IH-1000. 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 Bio-Rad Laboratories 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-00593-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-13
  • 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-00593-1
  • 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
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore this issue might lead to a wrong result released to the host if the 3 following conditions are met:1 a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, 2. this negative result is consistent with the global interpretation of the test and, 3. the system is configured without the second reading function activated for all tests results.
  • Action
    Bio-Rad are providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue.

Device

IH-1000. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    IH-1000. An in vitro diagnostic medical device (IVD)All software versions are affectedProduct reference: 001000ARTG Number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd