Events

Rappel de AQUIOS CL Flow Cytometry System. 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-01101-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-23
  • 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-2017-RN-01101-1
  • 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
    As a result of internal investigations, beckman coulter has learned that an erroneous configuration setting during servicing may be possible on the aquios cl instruments. if the incorrect configuration occurs, the probe may aspirate samples only from a single tube and will not aspirate samples from the remaining tubes in the cassette. the probe would repeatedly aspirate from a single tube position in the cassette, resulting in erroneous patient results for the remaining tubes in the cassette. this causes a mismatch between the test result given and the sample id.
  • Action
    1. Quality Control samples must be run utilising the control cassette and the autoloader. The controls will not pass if this issue exists on the unit, when run using the autoloader. If the controls do not pass, immediately contact a Beckman Coulter representative. 2. BEC Service organisation will be in contact to ensure that the configuration settings are correct.

Device

AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)Part Number: B30166ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd