Events

Rappel de BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK virus in whole blood, plasma and urine samples). 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-2016-RN-01041-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-05
  • 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-2016-RN-01041-1
  • 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 about difficulties to interpret low viral load in whole blood samples, a biomérieux investigation showed that the sensitivity of the bk virus r-gene of 260 copies/ml (corresponding to 2.41 log10) claimed in the ifu for whole blood was not confirmed. a limit of detection (lod) experiment conducted with whole blood samples has led to a lod value of 1578 copies/ml (corresponding to 3.20 log10).The issue only impacts whole blood samples with a low viral load (260 to 1578 copies/ml), where amplification leads to creeping/flat amplification curves that are difficult to interpret. these problems of interpretation could lead to:- a false negative result,- a delayed result until a new run or a new test is performed.This issue has no impact on negative results or on high positive samples, as the amplification curves are well identified and also, does not impact the test when urine or plasma samples are used.
  • Action
    bioMérieux is advising users that the Limit of Detection (LOD) is 1578 copies/mL rather than 260 copies/mL for whole blood samples until the root cause is identified and corrected. In addition, bioMérieux is advising that in case of doubt or for attended low viral load samples, testing should be performed on plasma or urine samples instead whole blood samples. Any concerns regarding previously reported results should be discussed with the Laboratory/Medical Director to determine the appropriate course of action. Following the completion of the manufacturer’s investigation, further actions may be undertaken.

Device

BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK ...
  • Modèle / numéro de série
    BK Virus R-gene Real-time Detection and Quantification Kit (used to measure the viral load of BK virus in whole blood, plasma and urine samples). An in vitro diagnostic medical device (IVD).Catalogue Number: 69-013BLot Numbers:1003909940, expiry 12-03-20171004754140, expiry 04-02-20181004764070, expiry 04-02-2018ARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd