Events

Rappel de VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). 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 Biomerieux 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-2016-RN-00159-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-10
  • 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-00159-1
  • 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
    Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, biomérieux performed an investigation concluding that the performance of vidas toxo igm kit while using with heat inactivated sera (56°c for 30 minutes) is not in accordance with the performance characteristics as stated in the ifu. the investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera and may result in false negative results. in remote cases this may result in a delayed diagnosis and treatment for immunocompromised patients, organ transplanted patients, foetuses (in the case of gestational infection) and neonates.
  • Action
    Biomerieux is advising users to not use heat inactivate sera before testing. Any concerns regarding previously generated results should be discussed with the Laboratory Director.

Device

VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic...
  • Modèle / numéro de série
    VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)Reference Number: 30202Multiple Lot Numbers affectedARTG Number: 209618
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd