Events

Recall of 942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas analyser. 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-2014-RN-00994-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00994-1
  • 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 lot r0530 of 942-073, d8088-crea a,d8089-crea b, membrane box for e8088 and e8089 electrodes has been packed in error with capsules of electrolyte solutions for glucose/lactate electrodes. testing by the manufacturer has established that the incorrect capsules of electrolyte solutions do not influence the performance of the crea results.
  • Action
    Radiometer is requesting their customers to discard remaining units from the affected lots. Alternative units are available. This action has been closed-out on 01/03/2016.

Device

942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas analyser. An in vitro ...
  • Model / Serial
    942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas analyser. An in vitro diagnostic medical device (IVD)Lot Number: R0530
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd