Events

Rappel de HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care 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 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-2012-RN-00749-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-07-26
  • 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-2012-RN-00749-3
  • 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
    Hemocue has become aware of indications of in-correct high readings of hemocue glucose 201 rt and hemocue glucose 201 dm rt for the application of monitoring of blood glucose levels on pre-term neonates. on full-term neonates there are no similar indications but as a precaution hemocue has decided to replace all systems on delivery and neonatal wards with hemocue glucose 201+ or hemocue glucose 201 dm while investigations continue.
  • Action
    HemoCue is recalling affected devices and is replacing them with unaffected models

Device

HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care in vitro diagnostic medical device ...
  • Modèle / numéro de série
    HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care in vitro diagnostic medical device (IVD). Affected Product Numbers: 124713 and 124013
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA