Events

Rappel de BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) 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 Becton Dickinson 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-2014-RN-00883-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • 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-2014-RN-00883-1
  • 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
    Bd epicenter allows for the integration of bd phoenix drug susceptibility results with bruker's maldi biotyper organism identification results within a single id/ast workflow.Bruker updated the maldi biotyper msp database where organism naming changes have been implemented. bd, unaware of these changes, did not implement corresponding changes to the bd epicenter database. this could lead to inconsistency of the orgnaism name between the bd epicenter and bruker maldi biotyper for a limited number of organisms.Bd has performed an analysis of the changes and determined that these inconsistencies either have no relevance to human care (relevant only to plant or animal infection) or have limited impact to human care due to no claims for id or ast in the bd phoenix system.
  • Action
    BD has developed a tool that will update the relevant data to ensure consistency between the MALDI BioTyper and BD EpiCenter systems after a Bruker MSP database change. This tool will be run by a BD Technical Service representative or can be applied through a remote connection. This action has been closed-out on 01/03/2016.

Device

BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medic...
  • Modèle / numéro de série
    BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medical device (IVD)Reference number: 441007ARTG number: 222680
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd