Events

Rappel de HemoCue WBC Diff analysers and WBC Diff Microcuvettes. 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 Radiometer Pacific 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-2018-RN-00161-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-19
  • 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-2018-RN-00161-1
  • 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
    No specific limitations are given in the indications for use for the system. however, hemocue has become aware that there is a need to clarify that use of the hemocue wbc diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects, has not been fully evaluated by hemocue ab.Riskif incorrect results are obtained for these patient populations it could potentially lead to a delay in a dose modification and increased infection risk.Hemocue will be updating the instruction for use for the wbc diff system to include the above clarification.
  • Action
    Radiometer will be providing updated instructions for use to provide clarification regarding the use of the HemoCue WBC Diff system on patients on chemotherapy, other immunosuppressive therapies or on drugs with immunosuppressive effects.

Device

HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    HemoCue WBC Diff analysers and WBC Diff Microcuvettes. An in vitro diagnostic medical device (IVD)All Serial NumbersARTG Numbers: 222568, 222701(Radiometer Pacific - Haematology full blood count IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd