Events

Rappel de AU480 Clinical Chemistry Analyser - software version 1.81(Systems configured with Closed Channels ONLY)

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-2015-RN-01011-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-10-19
  • 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-2015-RN-01011-1
  • 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
    A software defect has been identified on newly installed au480 systems with software version 1.81. the defect may generate incorrect test results for 2 step method assays on au480 systems configured with closed channels. the software defect occurs when edit and then confirm are pressed on the specific test parameters screen of closed channels. the result is that the measuring point-2 settings will be deleted. the measuring point 2 settings are used for sample blank adjustments for 2 step methods.For samples which may have lih (lipemia, icterus, hemolysis) or other interferant, there is a potential for false high results to be calculated for 2 step method assays on closed channels.
  • Action
    A Beckman Coulter FSE will visit each laboratory and change the closed channels to open channels. A set of action steps and associated instructions is also provided in the Customer Letter which Laboratories can use to determine if they have been affected. This action has been closed-out on 22/08/2016.

Device

AU480 Clinical Chemistry Analyser - software version 1.81(Systems configured with Closed Channels...
  • Modèle / numéro de série
    AU480 Clinical Chemistry Analyser - software version 1.81(Systems configured with Closed Channels ONLY) Part Numbers: B12183, B11810; B71362ARTG Number: 236636
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd