Events

Rappel de Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samples

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

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-00112-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-06
  • 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-00112-1
  • 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
    Roche diagnostics has confirmed that there is an increase in imprecision leading to higher results of the haemoglobin (hb) measurement when using capillary samples on the reflotron systems. testing with venous samples is not affected by this issue.
  • Action
    The use of capillary blood samples with Reflotron is no longer recommended. The package insert will be amended to reflect this change. It is recommended that the recall letter is retained with the Reflotron Hb test strips until the package insert has been updated.

Device

Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitati...
  • Modèle / numéro de série
    Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samplesMaterial Number: 10744964202All lot numbers
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited