Events

Rappel de UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System

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-2017-RN-00556-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-05-16
  • 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-2017-RN-00556-1
  • 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
    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.In most cases, system flags and/or messages have accompanied the erroneous results, indicating the need to review the results. in rare instances, system flags and/or messages might be absent.
  • Action
    Users are requested to: 1. Use all available features to assess patient results, including reference ranges, action and critical limits, instrument system flags, codes, messages, delta checks, and decision rules; 2. Follow all Instructions for Use (IFU) pertaining to flow cell error and warning messages, and ensure daily Shutdown is performed; 3. Follow your laboratory’s standard operating procedure for confirming unexpected results; 4. Communicate to your Laboratory Medical Director the need to avoid patient treatment based solely on any single test result, and to interpret all results in the context of other clinical and laboratory features; and 5. Consult with your Medical Director to determine if a retrospective review of results is warranted. In the interim, Beckman Coulter is working on a permanent resolution to detect and flag these unexpected light scatter patterns.

Device

UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Australia Pty Ltd