Events

Rappel de BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)

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-2018-RN-00072-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-25
  • 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-2018-RN-00072-1
  • 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
    As a result of continuous surveillance on antimicrobial resistance, becton dickinson (bd) are aware of newly recognised or emerging strains that may yield an increased rate of false susceptibility in in vitro antimicrobial susceptibility test (ast) results to colistin.The labelling currently provided with the bd gram negative panels (nmic) panels indicates that colistin susceptibility can be determined. emerging strains have led to an increased number of resistant isolates reporting as susceptible when tested using the bd nmic panels with bd phoenix instrumentation.
  • Action
    BD is advising users to perform an alternate method of testing prior to reporting susceptible colistin results. A resistant Phoenix colistin result does not require alternate testing. BD is not requesting that customers discard, return or discontinue use of the product. BD is also providing guidance for EpiCenter and BD Phoenix 100 &M50; instrument customers where rules can be created in the software to identify resistant isolates.

Device

BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)
  • Modèle / numéro de série
    BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)Catalogue Number: 448788 Lot Numbers: ALLARTG Number 197287 (Becton Dickinson Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd