Events

Rappel de AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. 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 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-2012-RN-01140-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-09
  • 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-01140-1
  • 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
    If the au5800 diluted detergent tank valve is not positioned to 'closed' during the instrument 'measure' mode, diluted detergent will not be dispensed and may adversely affect washing of cuvettes, probes and mixing-bars. inadequate washing of cuvettes, probes and mixing bars can cause falsely high or low results to be reported for a variety of tests.
  • Action
    Beckman Coulter is providing work around instructions to mitigate the issue and is asking customers to add a label to the diluted detergent tank identifying the "Open" and "Closed" orientation of the valve.

Device

AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnosti...
  • Modèle / numéro de série
    AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnostic medical device (IVD)Multiple models and catalogue numbersAll serial numbers affected
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd