Events

Rappel de VITROS Chemistry Products K+ Slides. 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-01238-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-21
  • 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-01238-1
  • 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
    While performing an internal investigation, ortho clinical diagnostics (ocd) determined that the coatings of the vitros chemistry products k+ slides contain a surfactant that was unintentionally added during the manufacturing process. the affected slides continue to meet intended use and performance specifications, however the long term product performance is unknown.
  • Action
    OCD is requesting their customers to discontinue use and discard all units from the affected lots. Replacement kits will be provided if required.

Device

VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITROS Chemistry Products K+ Slides. An in vitro diagnostic medical device (IVD)Catalogue Number: 8157596Coatings: 0884, 0885
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics