Events

Rappel de Elecsys HIV combi PT 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 Roche Diagnostics Australia Pty Limited.

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-00030-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-17
  • 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-00030-1
  • 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
    Recent cases have been reported of a calibration signal shift regarding the elecsys hiv combi pt assay (gmmi kit: 05390095-190) on modular analytics e170, cobas e 601 and e 602 analysers.The reagent packs reporting a calibration signal shift are affected during their use on the instrument. the affected on-board rack packs are identified by the hiv control level 1 (pc hiv level 1) recovering out of range (>3sd) during use.
  • Action
    Roche Diagnostics is recommending that if users are affected to not re-calibrate the rack pack, discontinue use of the affected pack, record rack pack details of QC and Calibration signals and use a fresh rack-pack with new calibration and follow the instructions given in the package insert. Discarded kits will be replaced by Roche Diagnostics. Roche Diagnostics are continuing to investigate the cause of the issue and will advise users when further information is available. This action has been closed-out on 29/01/2016.

Device

Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)Lot numbers: 171983, 172659, 173326, 175019, 175493, 175494
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited