Events

Rappel de AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. 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-01489-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-06
  • 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-01489-1
  • 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 noted an issue with duplicate sample requests when using the aquios cl systems connected to a laboratory information system (lis).1. host query errora) when aquios cl systems are connected to a laboratory information system (lis) directly or through middleware, the system may duplicate sample requests leading to sample mis-identification. 2. cassette unloading duplicationa) all aquios cl systems may duplicate sample requests if a cassette is not properly unloaded by the instrument. these sample duplications do not result in mis-identification. b) sample id duplication caused by errors with cassette unloading will present as non-sequential duplications. on the review and results screen, one or more sample ids from same instrument (serial number) will be listed with a run time between duplicate sample id entries. both issues described above are present in all software versions (2.0, 2.0.1 and 2.1) and all applications used on aquios cl are impacted.
  • Action
    Beckman Coulter is working on a software upgrade to permanently correct and eliminate these issues. In the interim, Beckman Coulter is advising users who are experiencing the identified issues to follow the instructions provided on the Customer Letter until the software upgrade has been released and installed. Beckman Coulter will be in contact with users to assist in determining whether previous samples run in laboratories were impacted by host query misidentifications. A retrospective review of results obtained is at the discretion of the Laboratory Manager.

Device

AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. An in vitro diagnostic medica...
  • Modèle / numéro de série
    AQUIOS CL Flow Cytometry System, software versions 2.0, 2.0.1, 2.1. An in vitro diagnostic medical device (IVD) Part Number: B30166 All Software Versions All Applications ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd