Events

Rappel de VITROS Chemistry Products MicroSlides (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 Ortho-Clinical Diagnostics.

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-2013-RN-00773-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-30
  • 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-2013-RN-00773-1
  • 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
    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
    Ortho Clinical is providing users with work around instructions to resolve slide dispense issues. Users are advised to replace the affected unit and contact Ortho Clinical for a replacement if they are unable to resolve a slide dispense issue by repositioning the ABP. This action has been closed-out on 12/02/2016.

Device

VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))
  • Modèle / numéro de série
    VITROS Chemistry Products MicroSlides (an in vitro diagnostic medical device (IVD))Multiple catalogue numbers affectedExpiry dates to 22 March, 2015ARTG Number: 25922
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics