Events

Rappel de NucliSENS Lysis Buffer. 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-00418-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-03
  • 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-00418-1
  • 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 coloured eluates, biomérieux's investigation confirmed an issue with a single lot of nuclisens lysis buffer. the eluate becomes coloured because of the presence of the heme group from the haemoglobin present in whole blood samples including dry blood spots. the root cause of the coloration is linked to the ph that, for the affected lot, has been observed to be 6.9 instead of 7.1 +/-0.1 as per product specification. the presence of haemoglobin causes the inhibition of the pcr. the result in most of the cases is uninterpretable test results as the internal control (ic) would also be inhibited, invalidating the test. in this case, there is a potential risk of delayed results. considering that the buffer is used in various protocols and downstream applications, and the worst case scenario in which the ic would not be inhibited, or not used although it is part of good laboratory practices, the tests run could potentially result in false negative results.
  • Action
    bioMérieux is advising users to stop using the affected lot of NucliSENs Lysis Buffer and to either quarantine or discard any stock of this lot. BioMerieux will arrange for pick up and credit, as required. Any concerns regarding previously reported results should be discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

NucliSENS Lysis Buffer. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    NucliSENS Lysis Buffer. An in vitro diagnostic medical device (IVD)Reference Number: 200292 Lot Number: 16092902 Expiry: 28 Aug 2018ARTG Number: 240760
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd