Events

Rappel de Liaison C-Peptid Assay. 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 DiaSorin 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-2017-RN-00323-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-10
  • 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-2017-RN-00323-1
  • 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
    A recent testing of liaison c-peptid assay by diasorin has highlighted the issue of cross reactivity with human proinsulin. this cross reactivity occurs in 100% of the tested samples and results in an increased c-peptide concentration in all samples tested, across all populations. for normal patients, the risk of falsely elevated results is rare, since the concentration of proinsulin in healthy fasting people is at least 100 times lower than the c-peptide concentration and therefore has only minimal effect on the results determined with the assay. patient populations of highest risk for falsely apparently elevated assay results are patients with insulin processing defects, renal malfunction, insulinoma or similar conditions.
  • Action
    DiaSorin is requesting users to confirm receipt of the “Urgent Recall for Product Correction” notification by completing the response section and returning it to DiaSorin. Users are advised of the possibility of further action pending TGA's receipt of additional information.

Device

Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD).Part Number: 316171All LotsARTG Number: 189435
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd