Events

Recall of cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range

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-01201-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01201-1
  • 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 become aware that the ccrea results for qc decreases to below the lower acceptance limit within the lifetime of the crea membranes. this has been experienced on membranes down to five days after installation of new membrane units.
  • Action
    Radiometer is advising their customers to perform one quality control measurement using S7835 AutoCheck 6+, level 1 (Item 944-094), on already installed Crea membrane units to verify the cCrea performance. If the QC result is out of range, please install new Crea A and Crea B membranes. Until further notice the following must be carried out every 24 hours: - Perform one quality control measurement using S7835 AutoCheck 6+, level 1 (944-094) to verify the cCrea performance. - If the QC result is out of range, new Crea A and Crea B membranes must be installed. This action has been closed-out on 05/08/2016.

Device

cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range
  • Model / Serial
    cCrea A+B Membrane Unit for use on the ABL800 series blood gas analyser range Item Number: 942-073ARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd