Events

Rappel de VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system

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-00096-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-04
  • 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-00096-1
  • 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
    Biomeriuex has identified that the inoculum density range for the neisseria haemophilus (nh) identification (id) test card in the vitek 2 7.01 product information document (ref: 514740-1en1) is incorrect. in section 6 - procedure for nh card specimen preparation (step 3), the documented densichek plus inoculum density range is 1.80 - 2.20. the correct density range is 2.70 - 3.30.The incorrect information is located on the dvd software for the vitek 2 7.01 system. all other product documentation has the correct inoculum density.
  • Action
    bioMerieux is advising end users of the incorrect inoculum density range and requesting that the recall letter be kept with the instrument documentation. bioMerieux will update the VITEK 2 7.01 Product Information to include the correct DensiCHEK inoculation concentration. This action has been closed-out on 09/08/2016.

Device

VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification ...
  • Modèle / numéro de série
    VITEK 2 System version 7.01. An in vitro diagnostic medical device (IVD).Bacteria identification and sensitivity system
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd