Events

Rappel de ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). 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-00286-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-15
  • 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-00286-1
  • 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 clinical diagnostics is issuing this notice due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui), the system will not detect the change. if users deviate from normal process for changing patient samples, these can be associated with another sample id, potentially leading to erroneous test results. in the unlikely event the error occurred, it may lead to an incorrect rh(d) or incorrect cross matching result. there have been no reports of patient injury.Update: ortho has advised an additional unlikely scenario where it is also possible for a user to unexpectedly remove or interchange diluents in a location that was not selected on the graphical user interface (gui) after making a reagents load/unload request.
  • Action
    Ortho Clinical Diagnostics is advising users to ensure samples, diluents and dilution trays are loaded and unloaded using the Graphical User Interface (GUI). The issue will be addressed in a future software version. Any concerns regarding previously generated results should be discussed with the Laboratory Director. This action has been closed-out on 02/02/2017.

Device

ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software ve...
  • Modèle / numéro de série
    ORTHO VISION Analyser, software version 2.12.6 & below and ORTHO VISION Max Analyser, software version 2.12.10 (for ORTHO BioVue Cassettes). An in vitro diagnostic medical device (IVD)ORTHO VISION Analyser for ORTHO BioVue Cassettes Software Versions: 2.12.6 and below Product Code: 6904579ORTHO VISION Max Analyser for ORTHO BioVue CassettesSoftware Versions: 2.12.10Product Code: 6904578ARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics