Events

Rappel de HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par HemoCue 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-00279-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-28
  • 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-00279-1
  • 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
    During extended investigations on neonates it was confirmed that hemocue glucose 201 rt and hemocue glucose 201 dm rt perform according to specifications in all neonatal settings except neonatal intensive care. critically ill neonates in intensive care settings often have immature metabolism in combination with complex treatment. this setting has not been fully evaluated for hemocue glucose 201 rt and glucose 201 dm rt. incorrect readings may lead to indirect harm to patients such as misdiagnosis or inappropriate treatment. therefore the following text will be added to the intended use: "the system should not be used on critically ill neonates in neonatal intensive care settings".
  • Action
    HemoCue is enclosing adhesive labels with the updated intended use along with the customer letters so that end users can use this to cover the current intended use in the Operating Manual, Technical Specifications etc.

Device

HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD)...
  • Modèle / numéro de série
    HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA