Events

Rappel de BD Vacutainer CPT Cell Preparation Tube. 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 Becton Dickinson 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-00704-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-02
  • 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-00704-1
  • 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
    Bd is conducting a recall of the above mentioned blood collection tube due to poor separation resulting in a reduced number of recovered mononuclear cells. having an insufficient number of isolated mononuclear cells may lead to possible specimen recollection, potential delay of treatment, and in remote cases, could lead to erroneous results.
  • Action
    BD is requesting their customers to check their inventory and quarantine product subject to this recall. BD will arrange for the collection and replacement of all affected stock.

Device

BD Vacutainer CPT Cell Preparation Tube. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    BD Vacutainer CPT Cell Preparation Tube. An in vitro diagnostic medical device (IVD).Catalogue Number: 362761Lot Numbers: 4063411 & 4090230ARTG Number: 177829
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd