Events

Rappel de Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems

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-2013-RN-01249-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-25
  • 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-2013-RN-01249-1
  • 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 have received reports of condition codes that occurred during the calibration of microwell assays. investigations have determined that the microwell shuttle weight may be uncoated and out of manufacturing specification. if an uncoated microwell shuttle weight is installed and calibration of microwell assays is performed, there is no effect on patient samples. if an uncoated microwell shuttle weight is installed and calibration is not performed, bias results could potentially occur. internal testing has determined that quality control results using an uncoated well weight showed, on average 10% shift from established means within the quality control ranges. ortho clinical investigations has shown there is not likely to be any impact on patient safety, however, if the results are at or near a decision cut off or reference interval, this could potentially move the result into the incorrect result classification.
  • Action
    Ortho Clinical Diagnostics (OCD) is advising users that a service technician will be inspecting all systems to identify if an uncoated MicroWell Shuttle Weight is in use and replace any affected units. If an uncoated MicroWell Shuttle Weight is identified and replaced, all MicroWell assays are required to be recalibrated. This action has been closed-out on 02/02/2016.

Device

Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated...
  • Modèle / numéro de série
    Micro Well Shuttle Weight used in VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated SystemsProduct Codes: 6802783, 6802413ARTG Number: 180199An in-vitro diagnostic medical device (IVD)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics