Events

Rappel de UniCel DxC ISE Reference reagent tubingUniCel DxC 600/800

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-00697-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • 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-00697-1
  • 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 a failure of the unicel dxc ise tubing (lines 11, 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticiser and the ise reference reagent. the supplier's change in plasticiser was due to a move to a phthalate-free tubing material based on new environmental regulations. as a result, a visible slow-forming non-microbial white material may appear inside the tubing. this may result in suppressed ise quality control and patient results due to reference drift errors and/or ise calibration failures and/or tubing lines 25 or 26 detaching due to obstruction of flow.
  • Action
    Users are requested to immediately perform a visual inspection of ISE Reference reagent tubing 11, 25, and 26 for the white material and in cases where material is identified a workaround is provided. In the longer term, Beckman Coulter is qualifying new ISE tubing and laboratories will be notified when new tubing is available to be installed on instruments subject to this Recall. This action has been closed-out on 02/05/2017.

Device

UniCel DxC ISE Reference reagent tubingUniCel DxC 600/800

Manufacturer

Beckman Coulter Australia Pty Ltd