Events

Rappel de VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. 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-01254-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-09-23
  • 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-01254-1
  • 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 has become aware that there is the potential for test results to be mis-associated with the wrong sample id (sid) and to be reported prior to the tcautomation system detecting a sid mismatch. this mis-match may occur when the centrifuge module fails to grip the sample tube when attempting to unload the centrifuge.The system will generate an error message for the unload failure, however the centrifuge will continue to operate as normal. the sample rack containing the sample that has not been unloaded will be transferred back to the load side of the centrifuge, and the system will not recognise that the sample is still in the rack. this may result in the sample being re-analysed and the sid being mis-associated. assay results are potentially associated with the wrong patient and may be reported. this could lead to misdiagnosis or inappropriate treatment of a patient. ortho received no reports of patient injury due to this issue.
  • Action
    Ortho is advising users to check samples associated with Cross Check errors when they appear on the TAC error messages screen, and to ensure preventative maintenance and cleaning procedures for the centrifuge are carried out as required. Past occurrences of this issue are not easily identifiable, and a review of previous results may be impractical. Ortho is recommending users discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/05/2017.

Device

VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro di...
  • Modèle / numéro de série
    VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro diagnostic medical device (IVD)VITROS Automation Solutions with TCAutomation System (TAC)Product Code: 6844300Software version: 3.6.2 and belowThermo Scientific Centrifuge ModuleProduct Code: 952040ARTG Number: 229946
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics