Events

Rappel de VIDAS 3 System (used with software version 1.1.4) 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-00331-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-03-14
  • 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-00331-1
  • 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
    Software anomalies have been discovered in the vidas 3 software version 1.1.4. the following are the limitations that could impact the system:1. the “error code 0550capu1” posted in case of tip lost does not suggest the appropriate troubleshooting 2. for customers using automatic pipetting mode: non-justified “error code 0400fapu1”3. stop section during analytical phase can induce drop on the strip or into the instrument4. for customers managing their internal/external quality control via quality control module of vidas 3 only5. for countries applying winter time change only.
  • Action
    bioMérieux is advising users to apply the required actions associated with the relevant limitation (as described in the customer letter). Users are further advised to discuss concerns about previously reported results with their Laboratory Medical Director to determine the appropriate course of action.

Device

VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VIDAS 3 System (used with software version 1.1.4) An in vitro diagnostic medical device (IVD)Catalogue Number: 412590ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd