Events

Recall of Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD) Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia 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-2015-RN-01035-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01035-1
  • 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
    Beckman coulter has determined that the access cea reagent packs were filled incorrectly. these packs contain insufficient quantity of reagents in one of the pack wells. the impact is dependent upon the instrument and software version installed at the time the reagent lot was in use: access 2 systems, software version 3.3.1 or lower, and access 2i systems, software version 6.1 or lower: - the instrument may have generated incorrect results of 0.0 ng/ml. all other results greater than 0.0 ng/ml are not affected by this issue and are correct. access 2 systems, software version 3.4.2 and access 2i systems, software version 6.2.2 or higher: - the affected packs would be detected by process monitoring, and the pack disabled by the instrument. no patient results generated. unicel dxi systems with all software versions: - the packs wouldbe detected by reagent pack monitoring, and the pack disabled by the instrument. no patient results generated.
  • Action
    Beckman Coulter is advising users to discard any remaining stocks of the affected lots. Beckman Coulter is recommending users review patients results that were reported as 0.0 ng/mL and did not match the clinical status of the patient, and advise clinicians at the discretion of the Laboratory Director. A software upgrade for Access systems to version 3.4.2 and Access 2i to version 6.2.2 rectifies this issue. This action has been closed-out on 02/05/2017.

Device

Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagn...
  • Model / Serial
    Access CEA Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)Used with systems: Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems. Part Number: 33200Lot Numbers: 595027 and 595029Expiry Date: 15 Feb 2016 and 28 Feb 2016ARTG Number: 213975
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd