Events

Rappel de TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). 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-2016-RN-00352-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-24
  • 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-2016-RN-00352-1
  • 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 electrical cable that supplies power to the cap vibratory feeder of the recapper module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. if this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.G., serum) may splash from the tube and into another tube or onto the under carriage of the support plate. this may result in contamination of patient samples and affect patient diagnosis or treatment.
  • Action
    Ortho Clinical is advising users to check the affected systems to identify if the electrical cable has migrated out of position. A Service Representative will secure the cable in place above the support vibration feeder plate. This action has been closed-out on 09/05/2017.

Device

TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An i...
  • Modèle / numéro de série
    TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD)TCAutomation SystemProduct Code: 6844300Thermo Scientific Recapper Module (230V)Product Code: 952036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics