Events

Rappel de Access hLH Calibrators used with Access Immunoassay Systems. 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 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-2012-RN-01142-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-12
  • 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-2012-RN-01142-1
  • 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
    The affected access hlh calibrator lots do not meet the stated expiration date claim. as a result, the quality control and patient sample results generated while using these calibrator lot numbers might be falsely elevated by as much as 13%. this can occur up to four months prior to the expiration date listed on the calibrator vial.
  • Action
    Beckman Coulter is advising users to discontinue the use of the affected calibrator and is providing updated work around instructions to mitigate the issue. Clinicians/research scientists should be notified regarding potentially affected results at the discretion of the Laboratory Director.

Device

Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical devic...
  • Modèle / numéro de série
    Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical device (IVD)Multiple Lot Numbers
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd