Events

Rappel de VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic 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-2013-RN-00168-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • 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-2013-RN-00168-1
  • 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
    Under specific conditions, vitek 2 60/xl and vitek 2 compact pc systems connected to a laboratory information system have the potential to link a test result to an incorrect patient record. the four conditions required to potentially cause an occurrence of this issue are:- patient demographics option is enabled- patient demographics are not associated with the isolate- user does not resolve qualified isolates- laboratory re-uses lab ids (accession numbers) prior to qualified isolates being resolved.
  • Action
    Biomerieux is updating the instructions for use (IFU), addendum to the software user manual, to include appropriate instructions for resolution of Qualified isolates as a short term action. Biomerieux is implementing a software solution to reduce the likelihood of occurrence of this issue in the next software update, version 7.01 targeted for launch in November 2013.

Device

VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacteri...
  • Modèle / numéro de série
    VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic sensitivity system) Used with the following PC models:Hewlett-Packard rp5700, Catalogue Number W0452Hewlett-Packard rp5800 XPE, Catalogue Number 413642Hewlett-Packard WES7, Catalogue Number 413862Hewlett-Packard dc7800, Catalogue Number W0449Hewlett-Packard dc7700 8-port, Catalogue Number W0447Hewlett-Packard dc7100 8-port, Catalogue Number W0441
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd