Events

Rappel de FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic 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 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-2018-RN-00271-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-19
  • 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-00271-1
  • 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
    Biomérieux australia has been advised that the manufacturer, biofire diagnostics, has identified an increased risk of false positive proteus results when the filmarray blood culture identification (bcid) panel is used with bd bactec blood culture bottles with expiration dates of september 30, 2018 and october 31, 2018. it is unknown if subsequent lots of media will also be subject to this risk; however, biofire and bd are continuing to investigate the issue.
  • Action
    bioMérieux is advising customers to verify positive results for Proteus by confirming with another method where BD BACTEC Blood Culture Bottles with expirations on 30/09/2018 and 31/10/2018 have been used due to the BCID Panel detecting nucleic acid from non-viable Proteus.

Device

FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottle...
  • Modèle / numéro de série
    FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic medical device. All lots of FilmArray Blood Culture Identification (BCID) Panel are impacted when used with specific BD media typesMultiple BD BACTEC Blood Culture Bottles with expiry dates of September 30 2018 and October 31 2018 may impact resultsARTG Number: 223979(Biomerieux Australia - Bacterial infectious disease IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd