Events

Recall of Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . 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-2012-RN-01108-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01108-1
  • 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
    Potential enzyme residue on the outside of a newly replaced lactate membrane may cause an initial negative bias on the reported lactate result. if this residue exists the bias will decrease over the in-use time.
  • Action
    Radiometer is providing work around instructions to mitigate the issue and are currently reviewing the manufacturing process to implement changes that will prevent the possibility of this occurrence

Device

Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . ...
  • Model / Serial
    Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . An in vitro diagnostic medical device (IVD)All lot numbers affected
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd