Events

Rappel de BK Virus R-gene kit when used on SmartCycler 2.0 platform. 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-2017-RN-00141-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-25
  • 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-00141-1
  • 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 customer complaint and an internal investigation, biomérieux has confirmed that when testing weak viral load samples, in conjunction with bk virus r-gene kit on smartcycler 2.0 platform, negative results may be obtained instead of positive as expected. the investigation confirmed that the issue has been observed only with smartcycler 2.0 and the issue only concerns low viral load samples (viral load equal or below the sensitivity control). the issue is detected by the sensitivity control (sc) that is the equivalent of a weak positive sample, which will be systematically negative instead of positive in most of the cases. when no sensitivity control is systematically run, there is a potential risk to obtain a false negative result. based on the investigation data, the performances claimed in the ifu regarding the use of smartcycler 2.0 in conjunction with bk virus r-gene kit could not be warranted.
  • Action
    bioMérieux is advising customers to stop using the BK Virus R-gene kit ref. 69-013B on Smart Cycler 2.0. It is recommended that any concern customers have regarding previously reported results is discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

BK Virus R-gene kit when used on SmartCycler 2.0 platform. An in vitro diagnostic medical device ...
  • Modèle / numéro de série
    BK Virus R-gene kit when used on SmartCycler 2.0 platform. An in vitro diagnostic medical device (IVD).(used for measuring the viral load of BK virus in whole blood, plasma and urine samples)Catalogue Number: 69-013BARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd