Events

Recall of Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). 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-2017-RN-00137-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00137-1
  • 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
    On the abl800 series analysers, the sample type “cord blood” has been changed into the two sample types “cord blood arterial” and “cord blood venous". this change took place with software version 3.1 mr5. despite the selected sample type being correctly displayed on the abl800 series analyser itself, the analyser will transmit the less specific sample type "cord blood" to a his/lis or middleware system. the described error may in a worst-case scenario lead to minor foetal hypoxic stress not being immediately recognised if the clinician was to use data from the his/lis or middleware system to determine treatment. this may cause a minor delay of necessary treatment of the newborn infant.
  • Action
    Radiometer is advising operators and clinicians using the "cord blood" sample results from a HIS/LIS or a middleware system to determine treatment to be aware that "arterial" or “venous" is not transmitted from the Analysers. Users are further advised that they will be notified when the new software fix is available for installation.

Device

Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic m...
  • Model / Serial
    Radiometer ABL800 Series Analysers (used with software version 3.1 MR5). An in vitro diagnostic medical device (IVD).All Serial Numbers connected to HIS/LIS or middleware Data Management systemARTG Number: 228382
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd