Events

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

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-2018-RN-00098-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00098-1
  • 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
    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