Events

Recall of Radiometer ABL90Flex analysers running V3.1MR1 or below

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific 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-2014-RN-01365-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01365-1
  • 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
    Radiometer has recently become aware of a potential significant clinical issue with patient results if the inlet is left open after aspiration of the patient sample for more than 30 seconds. if the inlet is accidentally left open after processing a patient sample the abl90 analyser sounds a warning bell, places a warning message on the screen and also initiates a voice message continuously repeating “please close the inlet”the problem can occur after the following sequence of actions:1. the operator aspirates patient sample a and forgets to close the inlet 2. the inlet is left open for more than 30 seconds before it is closed3. an operator aspirates patient sample bin this case the results for patient sample b are affected by this issue.Radiometer is currently developing a mechanism to be included in a future software upgrade to eliminate the possibility of this error. a label to be attached to the machine is provided to re-inforce the correct instructions for use.
  • Action
    Operators are reminded of the requirement to close the inlet when prompted by the analyser, as per the labelling and the Operator Manual. In the event the inlet is left open by mistake, a series of corrective steps is provided to customers as an interim measure. A warning label is also provided to customers to attach to the machine to re-inforce the correct instructions for use. Customers are advised that a look back over previous results may be required at the discretion of the Medical Director Radiometer is currently developing a mechanism to be included in a future software upgrade that will eliminate the possibility of this error. This action has been closed-out on 20/04/2017.

Device

Radiometer ABL90Flex analysers running V3.1MR1 or below
  • Model / Serial
    Radiometer ABL90Flex analysers running V3.1MR1 or belowARTG Number: 228382An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd