Events

Rappel de Ortho-Clinical Diagnostics VITROS Chemistry Products MicroSlides

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
    15144
  • Date de mise en oeuvre de l'événement
    2013-08-15
  • 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
    The vitros microslide cartridge is made up of the cartridge body and an anti-backup platen(abp). the purpose of the abp is to keep the stacks of slides in the correct position for dispensing. ortho clinical diagnostics have received reports associated with abp failing to advance, jamming or failing to stay locked in place within the cartridge. when this occurs, the slide is not properly dispensed from the cartridge since the stack of slides is not positioned correctly.
  • Action
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics VITROS Chemistry Products MicroSlides

Manufacturer

Ortho-Clinical Diagnostics Inc