Events

Rappel de Remisol Advance Software Versions 1.6-1.9, Architect Driver

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty Ltd.

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-2017-RN-01404-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-11-16
  • 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-2017-RN-01404-1
  • 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
    Beckman coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (“nocondition”) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. please note that the “nocondition” setting is not customer configurable through any instructions, but is reserved for field service configuration. if both conditions occur at the same time, i.E. the changed setting and a result outside of analytical range, an incorrect result could potentially be reported to the physician.
  • Action
    Beckman Coutler is advising users to check device settings as directed in the letter supplied to customers. If the setting is correct there is no further action required. If the setting is NOT correct, users should contact their local Beckman Coulter representative immediately, and either: (1) discontinue use of Remisol with the Architect instrument; or (2) monitor results sent from the Architect instrument to Remisol to ensure Remisol does not receive results outside the dynamic range from the Architect instrument.

Device

Remisol Advance Software Versions 1.6-1.9, Architect Driver

Manufacturer

Beckman Coulter Australia Pty Ltd