Events

Recall of Radiometer ABL800 FLEX series blood gas analysers with Crea module. 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-00900-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-07-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00900-1
  • 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 that measure ccrea may potentially report lower than expected ccrea results on patient samples. the difference has been reported to be as high as -28%.Currently, this problem may not identified by running the qc, as the qc will be lower, but still within range.The underestimated creatinine occurs specifically when measurements on autocheck 6+ level 1 (also known as s7835 autocheck module and abbreviated ac6+l1) are = 230 µm of a specified insert interval for ac6+l1 with insert limits 210–290 µm. ultimately, a lower read-out on patient samples on abl8x7 is observed.This issue may lead to erroneous measurement values for ccrea, and may lead to no detection of renal insufficiency or underestimation of moderate to severe renal failure.
  • Action
    Radiometer requests that users do not report cCrea results until they have verified the performance of the membrane units as described in the Customer Letter. Radiometer is advising that they are improving the cCrea membranes and will advise users accordingly when interim measures are no longer required.

Device

Radiometer ABL800 FLEX series blood gas analysers with Crea module. An in vitro diagnostic medica...
  • Model / Serial
    Radiometer ABL800 FLEX series blood gas analysers with Crea module. 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