Events

Rappel de Human IgG4 Kit Immage KitProduct code: LK009.IM

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-2014-RN-00991-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-15
  • 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-2014-RN-00991-1
  • 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
    As a result of customer complaints, the manufacturer (the binding site) identified that samples containing extremely high igg4 levels exhibit antigen excess and will yield spuriously low igg4 results.
  • Action
    In Vitro Technologies is advising that care must be taken when interpreting results from patients suspected of suffering from IgG4-RSD and recommend that for any patient where the IgG4 concentration does not concur with their clinical history or other test results, the sample should be re-assayed at different dilutions to identify if any antigen excess is occurring. In addition, the IgG4 result should be equated to the total IgG result and any significant discrepancies investigated. The instructions for use have been updated to include these recommendations. This action has been closed-out on 03/02/2017.

Device

Human IgG4 Kit Immage KitProduct code: LK009.IM

Manufacturer

In Vitro Technologies Pty Ltd