Events

Rappel de ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry Analysers. An in vitro diagnostic medical device (IVD)(clinical chemistry analysers)

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-2013-RN-01012-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-01
  • 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-01012-1
  • 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 confirmed that some ise units can experience premature ise ref (reference) valve failure. premature valve failure can be detected by the presence of air bubbles in the ise ref solution tubing on the ise unit. if air bubbles are present, accuracy of the ise test results may be affected. affected results may be clinically significant (high or low) and may impact patient diagnosis and/or treatment.
  • Action
    Beckman Coulter is providing users with instructions on how to inspect tubing for the presence of air bubbles. Where air bubbles are present, users are to contact Beckman Coulter for a replacement valve. Beckman Coulter is recommending consulting the laboratory director to determine the impact of this issue and if a retrospective review of prior results is necessary. As a preventative measure, Beckman Coulter is proving work around instructions for users to follow until a replacement ISE valve is implemented.

Device

ISE Reference Solenoid Valve for AU400, AU480, AU640, AU680, AU2700, AU5400 and AU5800 Chemistry ...

Manufacturer

Beckman Coulter Australia Pty Ltd