Events

Recall of AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00476-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00476-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Beckman coulter has confirmed that the export feature located in the results area of the aquios system software is not correctly exporting tetra combo crd files. upon import of the exported file to another aquios workstation, two individual files will be generated in the results tab rather than one combo file. the data and results on the acquisition system are not impacted. the possibility for erroneous results will occur under the following sequence of events:- using the export button to export a tetra combo crd file from the acquisition system; and- importing the data into a different system with a highly populated database; and - moving a region in any of the plots will generate erroneous results upon recalculation of the data.
  • Action
    Beckman Coulter will be addressing the issue in a subsequent software release. In the interim, Beckman Coulter is advising users to not use the Export button located in the Results area to export Tetra Combo CRD files and to export the files using the export icon, which exports the run displayed on the screen. For further instructions, users should refer to the AQUIOS Instructions for use, PN B21896 AD, Chapter 6- Data Review.

Device

AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. An in vitro diagnostic medica...
  • Model / Serial
    AQUIOS CL Flow Cytometer utilising software versions 2.0 and 2.0.1. An in vitro diagnostic medical device (IVD)Reference Number: B30166ARTG Number: 208574
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd