Events

Rappel de VITROS 5,1 FS System

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-2015-RN-00607-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-07
  • 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-2015-RN-00607-1
  • 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 has received two complaints:1) when a customer installed the add that supported the new vitros chemistry products hba1c reagent kit, the vitros 5,1 fs system posted the two condition codes ua7-239 and syd-024. the condition codes occurred because the short assay name for the new vitros assay had the same name as a user defined assay currently in use on their vitros 5,1 fs system. as a result, the user defined assay target was deleted from their system.2) when a customer installed the add, their system became unresponsive (screen freeze occurred) that required the vitros 5,1 fs system to be restarted; the system posted condition code uz0-047 after the restart was initiated.Due to a software coding error, for both scenarios, all default settings were restored from the add instead of retaining the user modified (configured) parameters and the operator was not alerted by the system.
  • Action
    OCD has determined that the root cause of this anomaly is due to an error in the software code. The resolution is currently under development and will be available in a future version of software. In the interim, OCD has provided workaround instructions to assist end users mitigate this issue. This action has been closed-out on 15/08/2016.

Device

VITROS 5,1 FS System
  • Modèle / numéro de série
    VITROS 5,1 FS SystemProduct Codes: 6801375 and 6801890Unique Device Identifier Number: 10758750001132 and 10758750001644ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics