Events

Rappel de D-10 Haemoglobin Testing System. 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-2014-RN-00280-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-04
  • 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-2014-RN-00280-1
  • 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
    On a rare occasion, the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample. the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • Action
    Bio-Rad are providing users with work around instructions to follow as an interim measure. Bio-Rad will release a permanent solution when available. This action has been clsoed-out on 18/02/2016.

Device

D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)Catalogue Number: 220-0220
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd