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-01101-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01101-1
  • 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
    As a result of internal investigations, beckman coulter has learned that an erroneous configuration setting during servicing may be possible on the aquios cl instruments. if the incorrect configuration occurs, the probe may aspirate samples only from a single tube and will not aspirate samples from the remaining tubes in the cassette. the probe would repeatedly aspirate from a single tube position in the cassette, resulting in erroneous patient results for the remaining tubes in the cassette. this causes a mismatch between the test result given and the sample id.
  • Action
    1. Quality Control samples must be run utilising the control cassette and the autoloader. The controls will not pass if this issue exists on the unit, when run using the autoloader. If the controls do not pass, immediately contact a Beckman Coulter representative. 2. BEC Service organisation will be in contact to ensure that the configuration settings are correct.

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: B30166ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd