Events

Recall of Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Access Family of Immunoassay Systems including 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-00724-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00724-1
  • 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
    The access thyroglobulin reagent pack lots may generate falsely elevated results at concentrations <10 ng/ml. the estimated maximum magnitude of the potential error in the affected range is a shift of up to 0.36 ng/ml high at concentrations <10 ng/ml. acceptable total imprecision was observed at values of 10 ng/ml and higher.
  • Action
    Beckman Coulter is requesting their customers to discard all Access Thyroglobulin reagent pack from the affected lots. Retesting should be carried out at the discretion of the laboratory director. This action has been closed-out on 26/08/2016.

Device

Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD) For use with the Ac...
  • Model / Serial
    Access Thyroglobulin Reagent Kit. An in vitro diagnostic medical device (IVD)For use with the Access Family of Immunoassay Systems including 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.Product REF - 33860Lot Number:430969 431990 434727 522896 523251
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd