Events

Rappel de Dako Beta-2-Microglobulin PET Kits. 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 Elitechgroup 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-2015-RN-00331-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-14
  • 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-2015-RN-00331-1
  • 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
    There is a stability issue with a single component of the kit, vial 1 beta-2-microglobulin immunoparticles. investigations have shown that a change in the ph value in the beta-2-microglobulin immunoparticles (vial 1) has occurred resulting in low or no signal for the 2 lowest standards in the calibration curve. the identified change in the ph value may affect the accuracy of beta-2-microglobulin values/results obtained, without any warnings from instruments. the beta-2-microglobulin values may be measured up to 20% higher for samples in the clinically elevated ranges.
  • Action
    ELITech Group is advising users to cease use of the affected lot and discard any remaining inventory. This action has been closed-out on 18/07/2016.

Device

Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Dako Beta-2-Microglobulin PET Kits. An in vitro diagnostic medical device (IVD) Product code: K0052Lot Number: 20012249ARTG number: 200116
  • Manufacturer
    Elitechgroup Australia PTY LTD

Manufacturer

Elitechgroup Australia PTY LTD