Events

Rappel de BD CD8 Phycoerythrin (PE)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par manufacturer #1479.

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
    17921
  • Date de mise en oeuvre de l'événement
    2014-12-24
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Cause
    It has been identified that the cd8 pe reagent has been contaminated with a low amount of cd4 fitc. it has been confirmed that the concentration of the cd8 antibody in the oe conjugate is sufficient to detect cd8 antigen on the targeted cells however the presence of cd4 could result in the possibility of an unexpected staining pattern., the concern with the above issue is that the cd4 cells will be expressed along the fitc axis. any marker that is stained on the fitc axis will contain this incorrectly stained cd4 population. subsequent downgating will make the data appear as if the cd4 population is not present.
  • Action
    Product to be exchanged

Device

BD CD8 Phycoerythrin (PE)
  • Modèle / numéro de série
    Model: 340046, Affected: 4220622
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479