Events

Rappel de Coverstainer Slide Rack (automated staining instrument). 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 Dako Australia Pty Ltd.

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-2012-RN-01198-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-03
  • 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-2012-RN-01198-1
  • 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
    Based on an investigation it has been concluded that the expected lifetime of the coverstainer racks does not meet the set requirements. the consequence can be that slides are falling out of the rack during the staining process. slides falling out of the rack during the staining process would require a new slide preparation and staining process to be initiated. in the rare event, the patient may need to be called in for a new sample to be taken.This recall action was not notified to the tga before it was initiated by dako australia.
  • Action
    Dako Australia Pty Ltd has advised their customer to discontinue use and return the Coverstainer Slide Racks for replacement.

Device

Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)Model number: CS10330ARTG: 181957
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd