Events

Rappel de UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). 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-01619-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-13
  • 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-01619-1
  • 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 determined that certain lots of dxc wash concentrate ii can cause a failure in calibration of thermo-fisher lithium reagent (ref a19611). the consequence of calibration failure does not allow for patient results to be generated. lithium calibration failure can potentially lead to a delay of reporting lithium results. patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.
  • Action
    Beckman Coulter is advising Thermo-Fisher Lithium assay users to discontinue use of affected DxC Wash Concentrate II lots and discard any unused reagent bottles. Replacement product will be provided. Reassessment of past results is not required.

Device

UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611)...
  • Modèle / numéro de série
    UniCel DxC Synchron Wash Concentrate II when used with Thermo-Fisher Lithium reagent (Ref A19611). An in vitro diagnostic medical device (IVD).Wash Concentrate IIReference Number: 445865Lot Numbers: Z505212 (expiry 30 April 2017), Z507201 (expiry 30 June 2016), Z511202 (expiry 31 October 2017)ARTG Number: 245295
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd