Events

Recall of D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analysers (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-2013-RN-00726-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00726-1
  • 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 medical has become aware that some pco2 membranes can cause a negative bias, on both blood and quality control measurement results.The bias can be seen after the replacement of the membrane.
  • Action
    Radiometer Medical are providing additional quality control instructions to ensure the accuracy of pCO2 results. This action has been closed-out on 10/02/2016.

Device

D788 pCO2 Membrane (catalogue number 942-063) used with Radiometer ABL700 and ABL800 series analy...

Manufacturer

Radiometer Pacific Pty Ltd