Events

Rappel de Freelite Human Lambda Free kit for use on SPAPLUS

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par In Vitro Technologies 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-2016-RN-01425-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-09
  • 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-2016-RN-01425-1
  • 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 manufacturer has advised that investigations of the products have identified a change in the calibration curve shape that has occurred since product release. increased activity in the calibration curve between calibrators 5 and 6 has been observed and they have received reports of increased false prozone flags which is consistent with this issue.
  • Action
    Customers are advised to immediately quarantine and dispose of any affected lots held by the customers and also to remove any affected lots from the SPAPLUS instrument. It is also advised to discuss the issues with the Medical Director to identify any further actions are required including reviewing the previously reported results.

Device

Freelite Human Lambda Free kit for use on SPAPLUS
  • Modèle / numéro de série
    Freelite Human Lambda Free kit for use on SPAPLUSItem Numbers: TBSLK018S, TBSLK01810SLot Numbers: 400012, 400257Expiry: Nov 2017
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd