Events

Recall of Access Free T3 Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)T he Access Family of Immunoassay Systems includes the 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-01042-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01042-1
  • 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 some access free t3 reagent packs were filled incorrectly. beckman coulter has determined and confirmed that thirty-two access free t3 reagent packs are affected by this issue. these packs contained insufficient quantity of reagents in one or more of the pack wells. this may give rise to inaccurate test results and/or delays in therapy.There has been no report of death or injury related to this defect.
  • Action
    Customers are asked to discard affected lots numbers and to initiate a review of patient results as per the discretion of the Medical Director. This action has closed-out on 19/08/2016.

Device

Access Free T3 Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro d...
  • Model / Serial
    Access Free T3 Reagent Kit (For use with the Access Family of Immunoassay Systems). An in vitro diagnostic medical device (IVD)The Access Family of Immunoassay Systems includes the 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 systemsCatalogue Number: A13422 Lot Number: 431433ARTG Number: 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd