Events

Rappel de LIAISON Borrelia IgG. 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-2014-RN-01240-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-21
  • 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-01240-1
  • 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
    Diasorin has become aware that the kit lots identified have a potential to produce invalid calibrations due to either a calibrator 1 deviation percentage [%] outside the high limit, or due to the gcc (geometrical curve check) out of range. as a consequence the calibration cannot be validated and the testing with these lots on the analyser cannot be performed.
  • Action
    Diasorin is recommending that use of the affected lot be ceased and any units be discarded. Results obtained with a valid calibration are considered to be reliable; therefore, review of past patient results is not deemed necessary, but at the discretion of the laboratory director. This action has been closed-out on 01/03/2016.

Device

LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    LIAISON Borrelia IgG. An in vitro diagnostic medical device (IVD).Part number: 310880Lot Number: 089054X , 089054X/1 and 089054X/2Expiry date January 9th, 2016 for all three lots ARTG number: 208811
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd