Events

Rappel de Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.

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-01259-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-12-23
  • 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-01259-1
  • 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 received an increased number of customer complaints observed after s-cal calibration on the unicel dxh 800 and dxh 600 coulter cellular analysis systems, and the coulter lh 750 and lh 780 hematology systems. customers have reported a variety of issues during calibration including:- an increase in h&h; check messages- low mch recovery in xb- low mchc recovery in xbthese issues are not observed with all analysers and there is no impact to patient results.
  • Action
    Beckman Coulter is advising users to monitor other quality control performance and adhere to the established maintenance schedule. Beckman Coulter is adjusting the SCAL values for lots starting 4782 and 113160400. This action has been closed-out on 16/05/2017.

Device

Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems.
  • Modèle / numéro de série
    Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems. Catalogue Numbers: 624519, 179310 and 628026Multiple Kits and Vial Lot Numbers affectedAn in vitro diagnostic device (IVD)ARTG Number: 223050
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd