Events

Rappel de VITEK MS Clinical Systems. 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-00909-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-03
  • 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-00909-1
  • 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
    The vitek ms system could give, in specific conditions, an incorrect identification result if the tested species is not included in the vitek ms knowledge base (kb). when the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison. consequently, the system can give:1) no identification when the spectrum acquired does not match with any species pattern.2) a low discrimination identification when the spectrum acquired presents a high level of similarity with multiple specific species patterns present in the database.3) an incorrect single choice identification to the nearest pattern species when the spectrum acquired presents a high level of similarity with a specific species pattern present in the database.This is a system limitation with all maldi-tof databases which is currently not described in the user manual.
  • Action
    Biomerieux is requesting customers: 1. Distribute the supplied information to all appropriate personnel in your laboratory, retain a copy in your files, and forward the customer letter to all parties that may use this product, including others to whom you may have transferred our product; 2. Take this limitation into account; 3. Contact your local Customer Service in case of questions; and 4. Complete and return the supplied Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice

Device

VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITEK MS Clinical Systems. An in vitro diagnostic medical device (IVD)Reference Number: 410895Software version: V2 / KB CLI_2.0 ex-US Acquisition station: V2.0 : ref 411032ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd