Events

Rappel de Human IgM Kit for use on SPA Plus. 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 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-2013-RN-01157-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-15
  • 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-2013-RN-01157-1
  • 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
    Manufacturer investigations identified that the affected product may be subject to antigen excess effect; even though it's true value was below the claimed level of 56.4g/l. the antigen excess capacity of this product has been reviewed and has been confirmed as correct. investigations have suggested that the tested sample contained predominantly monoclonal igm and the manufacturer believes that this particular type of igm reacted aberrantly with the antibody and subsequently yielded this spurious result.
  • Action
    In Vitro Technologies is advising end users of the issue and are updating the instructions for use to reflect the new performance information.

Device

Human IgM Kit for use on SPA Plus. An in vitro Diagnostic Medical Device (IVD)
  • Modèle / numéro de série
    Human IgM Kit for use on SPA Plus. An in vitro Diagnostic Medical Device (IVD)Product Codes: NK012.S & NK012.10SAll lot numbers affectedARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd