Events

Rappel de AQUIOS CL Flow Cytometry System. An in vitro medical device.

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-2018-RN-00098-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-02-19
  • 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-2018-RN-00098-1
  • 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
    Aquios cl system will associate the wrong sample id with results in the event the following sequence occurs: -the stat button is selected within aquios cl software and the user opens the single-tube loader door. - user creates a test request when prompted, places a specimen tube in single tube loader, and closes the single-tube loader door. - the stat button is selected again and the user opens the single-tube loader door within 15 seconds or less of loading the first sample and before the “details” column on running screen changes to “prepping” for that sample. - user removes the first specimen tube and replaces with a different specimen tube. this issue was discovered internally during a verification test. there have been no reported similar events from the field.
  • Action
    Beckman Coulter has released the software correction for this issue at the end of January 2018. A Beckman Coulter Field Service Engineer will contact users to schedule the installation of the software upgrade. In the interim, users are advised to follow the steps and warnings outlines in the IFU when running STAT specimens to avoid sample mis-identification. When running multiple specimen via the single tube loader, wait for the currently loaded specimen to be in the "incubating" status in the "details" column on the Running screen before selecting the STAT button or attempting to cancel the run.

Device

AQUIOS CL Flow Cytometry System. An in vitro medical device.

Manufacturer

Beckman Coulter Australia Pty Ltd