Events

Rappel de A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (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 Beckman Coulter 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-2013-RN-00056-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-21
  • 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-00056-1
  • 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
    Beckman coulter has identified an internal wiring problem in certain navios reagent carts that may result in a severe shock hazard and instrument failure or shut down. during manufacture the compressor cable assembly may have been installed in a configuration that would allow the wiring to come into contact with the compressor frame during operation. normal vibration of the compressor frame could wear through the wiring's shielding and insulation material and connect electrical current to the reagent cart housing, resulting in the potential exposure of a user or service engineer to a severe shock hazard.
  • Action
    If the compressor fails or the system shuts down unexpectedly, unplug the laboratory power source and call Beckman Coulter Customer Service. A Beckman Coulter service engineer will be contacting the affected customers to arrange for an inspection of the device and make all necessary corrections if an issue exists with the wiring within the compressor module.

Device

A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 La...
  • Modèle / numéro de série
    A52103 Navios 10 Colours/3 Lasers, A52102 Navios 8 Colours/2 Lasers, A52101 Navios 6 Colours/2 Lasers (Navios Flow Cytometers). In vitro diagnostic medical devices (IVD)Part number A52101 serial numbers earlier than AU50137 are affectedPart number A52102 serial numbers earlier than AU50014 are affectedPart number A52103 serial numbers earlier than AU45311 are affected
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd