Events

Rappel de Coulter LH and HmX Analysers. 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-2017-RN-00820-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-06-27
  • 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-00820-1
  • 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 additional clarification for the blast suspect messages is necessary. in rare situations, the lh 750, lh 780, lh 500 and hmx analysers may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as the properties of blasts in certain samples. if these limitations are not clearly understood or are misinterpreted, in rare situations there could be a delay in the recognition, diagnosis and treatment of conditions associated with blasts in the peripheral blood.
  • Action
    Users are asked to refer to the modified information for both the Suspect messages and Limitations sections for the Differential as contained in the Customer Letter.

Device

Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Coulter LH and HmX Analysers. An in vitro diagnostic medical device (IVD)Coulter LH 750 AnalyserReference Numbers: 6605632, A85570, A68807 Coulter LH 780 AnalyserReference No: 723585, A90728, A68808 Coulter LH 500 AnalyserReference No: 178832, 178833, 178834, A91062, A90994 Coulter HmX CP AnalysersReference No: 6605522, 6605523, 6605524 Coulter HmX AL AnalysersReference No: 6605525, 6605526, 6605527, A85566, A85564 All software versionsARTG Number: 177999
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd