Events

Rappel de BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). 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-2012-RN-00995-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-09-26
  • 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-2012-RN-00995-1
  • 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 the bd max instrument may have minor defects that could cause the instrument to malfunction yet is unlikely to cause erroneous results. the minor defect(s) may be due to the following:1) a potential misalignment of the filters/lens in the reader assembly that can produce reaction curves with excess variability2) a supplier defect on a limited number of mux heater board assemblies.
  • Action
    Becton Dickinson Service Associate to inspect the instrument and perform corrections if required

Device

BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection in...
  • Modèle / numéro de série
    BD MAX (6 channel) Instruments (Automated specimen preparation and PCR amplification/detection instrument). An in-vitro diagnostic medical device (IVD)Catalogue Number: 441916Serial Numbers: CM0053 and CM0105
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd