Events

Rappel de BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)

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-2013-RN-01315-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-13
  • 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-01315-1
  • 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 has determined that some db bactec fx instruments contain racks that may demonstrate variable indicator light intensities. specifically, the anonymous vial indicator lights, which should appear yellow, may instead appear green in colour. this has the potential to lead a user of the instrument to accidentally discard an anonymous vial or the readings associated with an anonymous vial, before an anonymous vial has completed protocol. the affected instruments continue to function properly and will not report an incorrect result.
  • Action
    BD is providing a software update to correct the issue, which will be available in February 2014. As an interim measure, BD is providing users with work around instructions to follow until the software upgrade is completed.

Device

BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)
  • Modèle / numéro de série
    BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)BD BACTED FX - Top UnitReference Number: 441385Serial Numbers: FT2899, FT2914, FT2951 & FT3077BD BACTEC FX - Bottom UnitReference Number: 441386Serial Numbers: FB1724 & FB1756
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd