Events

Recall of AQUIOS CL Flow Cytometry System. 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-01325-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01325-1
  • 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 determined that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis- identification. for this to occur, the following conditions must be met:- the aquios cl flow cytometer is connected to an lis; and- the aquios cl system has the default test enabled; and- host query is enabled in lis setup screen on system; and- there are multiple cassettes in the autoloader; and- the lis host query response is received in a brief time window before lis response timeout occurs.When all of these conditions are met, a sample will follow two paths of test request creation (lis and default test). all software versions (2.0, 2.0.1 and 2.1) in existence are impacted by this issue and all applications used on the aquios cl are impacted by this issue.
  • Action
    Beckman Coulter is advising users to immediately perform an adjustment to the software options on the system by turning off the DEFAULT TEST. This will eliminate the issue and result in one sample producing one set of results. After doing this, samples with no LIS test requests will become entries in the incomplete tab. Beckman Coulter will be contacting laboratories to assist in determining if any samples previously run are impacted.

Device

AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    AQUIOS CL Flow Cytometry System. An in vitro diagnostic medical device (IVD)Part Number: B30166All software versions (2.0, 2.0.1 and 2.1)All applications used on the AQUIOS CL SystemARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd