Events

Rappel de Parechovirus r-gene. 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-2015-RN-00579-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-29
  • 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-2015-RN-00579-1
  • 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
    An internal investigation identified a shift of the ct values of lnternal control (ic1 w0, internal control with water) inside and outside the limit of specifications. the investigations performed by r&d; with ref. 71-020 lot 1002978600 showed that ct values results on the extraction control (ic1w0) with ct value close to the specification of validity (32 ct) or just above this specification. the ct shift values may be observed on a positive sample without impacting the limit of detection.
  • Action
    Biomerieux is requesting their customers to discontinue using and discard any remaining inventory of the Parechovirus r-gene ref. 71-020 (WW) lot 1002978600. This action has been closed-out on 17/08/2016.

Device

Parechovirus r-gene. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Parechovirus r-gene. An in vitro diagnostic medical device (IVD)Catalogue Number: 71-020Serial Number: 1002978600Supplied as Research Use OnlyARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd