Events

Recall of Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. 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 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-2018-RN-00926-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00926-1
  • 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 that the abl800 series analysers could potentially induce a patient mix-up when “confirmation of demographics” is enabled as part of the query to aqure, radiance, or a his lis system. please note that the default setting for this function is ‘disabled’.The described error may potentially impact upon patient management as the physician may subject the patient to unnecessary treatment or erroneously withhold necessary treatment from the patient based upon the mixed-up of patient identification. in a worst-case scenario, where a critical parameter, such as k+ or po2, is interrogated, based upon a false clinical diagnosis inferred from the erroneous measurement, a critically ill patient may be subjected to lack of critical treatment.
  • Action
    Radiometer is advising that they are currently working on revising the software to correct this issue. Once release, a Radiometer representative will contact users to schedule a visit for the software upgrade. In the interim, users are requested to confirm if "Confirmation of Demographics" is disabled on their analysers. If disabled, the issue will not be experienced. If enabled, one of the two following counter-measures (CM) must be implemented: CM #1: Disable “Confirmation of Demographics” as follows: a. Logon to the analyzer. b. Select “Menu” > “Utilities” > “Setup” > “General Setup” > “Communications” > “Automatic Data Request” c. Remove the checkmark for “Confirm requested data”, if present. d. Select “Close”. Or CM #2: If disabling the “Confirmation of Demographics” (CM #1) is not possible due to e.g. internal procedures, instruct all operators of the analyser(s) to not introduce a new sample when the menu for “Confirmation of Demographics” is being displayed.

Device

Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. An in ...
  • Model / Serial
    Radiometer ABL800 blood gas analysers with software versions 6.14 through to Version 6.18. An in vitro diagnostic medical device (IVD). ARTG Number: 228382(Radiometer Pacific Pty Ltd - Instrument/analyser IVDs)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd