Events

Rappel de UniCel (DxH 800/DxH 600/ DxH Slidemaker Stainer) Coulter Cellular Analysis Systems. 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-2016-RN-00423-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-04-08
  • 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-2016-RN-00423-1
  • 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
    The dxh 800, dxh 600, and dxh slidemaker stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions, daily checks failures, lis disconnection, and printer failures at:· the alert status icon(s) on the system manager· the audible alarm at the system manager· the instrument beacon on the specimen processing module or slidemaker stainerthe failure may occur when the system manager application is restarted or powered off/on.When the failure occurs the user may not notice the need to change reagents before depletion, instrument operation will continue and, information about reagent levels shown on the supplies screen, results on the daily checks screen, and the status of the lis connection and printer on the system status screen are correct.
  • Action
    Beckman Coulter is advising users to monitor the reagent levels and status on the reagent Supplies screen. The ‘Cycles Remaining’ field is located at the bottom of the screen, above the local navigation buttons. The field will be highlighted yellow (warning) or red (error) when a reagent is low or depleted. Users should monitor the status of the LIS and/or Printer using their graphics on the System Status screen. Red, grey, or black status spheres within a graphic indicate possible concerns. A software correction will in implemented as a permanent fix.

Device

UniCel (DxH 800/DxH 600/ DxH Slidemaker Stainer) Coulter Cellular Analysis Systems. An in vitro d...
  • Modèle / numéro de série
    UniCel (DxH 800/DxH 600/ DxH Slidemaker Stainer) Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)UniCel DxH 800 Coulter Analysis System Reference # 629029, B24465, B24802, B68304 Software versions: 2.0.0.0 & greaterUniCel DxH 600 Coulter Cellular Analysis SystemReference # B23858Software versions: 1.0.0.0 & greaterUniCel DxH Slidemaker Stainer Coulter Cellular Analysis SystemReference # 775222 s/w versions: 1.5.0.0 & greaterARTG # 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd