Events

Rappel de VITROS 5600 Integrated System. 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-00228-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-29
  • 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-00228-1
  • 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
    Ortho is providing information regarding the potential for four wires connected to the power supply to have been misconfigured within vitros 5600 system(s) during manufacturing. the electrical wires are located in an area that is intended to be accessed only by an ortho-trained service representative. normal use, maintenance and troubleshooting on vitros 5600 system will not expose an operator to electrical hazards as a result of this issue.If a system has the incorrect wire configuration, it is possible that if the power to an individual module is intended to be shut off, it will remain on. however, there is no risk to ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the vitros 5600 system as a whole prior to working on a component.
  • Action
    Customers are advised that there is no impact to the results generated with an affected system. An Ortho representative will be inspecting the wiring of all affected systems and will reconfigure the wiring where required. This action has been closed-out on 09/05/2017.

Device

VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)Product Codes: 6802413 and 6802915ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics