Events

Rappel de Vitros Chemistry products K+ Slides, Coatings 0884 amd 0885

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 Ortho-Clinical Diagnostics Inc.

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
    15699
  • Date de mise en oeuvre de l'événement
    2013-11-22
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • Cause
    Ortho clinical diagnostics (ocd) determined that vitros® chemistry products k+ slides, coatings 0884 and 0885 contain a surfactant that was unintentionally added during the manufacturing process. ocd has conducted testing that indicates that vitros® k+ slides made from coatings 0884 and 0885 are currently meeting their intended use and performance specifications. however, at this time we are unable to determine the effect that the addition of the surfactant may have on long-term product performance.
  • Action
    Product to be destroyed

Device

Vitros Chemistry products K+ Slides, Coatings 0884 amd 0885

Manufacturer

Ortho-Clinical Diagnostics Inc