Events

Rappel de VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (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-2013-RN-01051-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-11
  • 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-01051-1
  • 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
    Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old transient recorder (tr) board (ref. 6200350). extensive testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board, with a risk of repeated results for different spots. this issue does not occur if firmware version 3.13 is installed with the new tr board ae8679ad (ref. 6200720).
  • Action
    Biomerieux is requesting users to reboot the instrument if the board freezes. Biomerieux is advising users that the new TR board is required to have firmware V3.13, and the old TR board is required to have firmware version V3.10. Biomerieux is contacting users to migrate the firmware if required.

Device

VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses t...
  • Modèle / numéro de série
    VITEK MS, firmware version 3.10 and 3.13 (bacterial and fungal identification system which uses the matrix-assisted laser desorption / ionization (MALDI) mass spectrometry method) (an in vitro diagnostic medical device (IVD))Catalogue Number: 410895Serial Numbers: Lower than #50039, #50050, greater than or equal to #60000ARTG Number: 199422
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd