Events

Recall of Access hLH Calibrators used with Access Immunoassay Systems. 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 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-2012-RN-01142-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01142-1
  • 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 affected access hlh calibrator lots do not meet the stated expiration date claim. as a result, the quality control and patient sample results generated while using these calibrator lot numbers might be falsely elevated by as much as 13%. this can occur up to four months prior to the expiration date listed on the calibrator vial.
  • Action
    Beckman Coulter is advising users to discontinue the use of the affected calibrator and is providing updated work around instructions to mitigate the issue. Clinicians/research scientists should be notified regarding potentially affected results at the discretion of the Laboratory Director.

Device

Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical devic...
  • Model / Serial
    Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical device (IVD)Multiple Lot Numbers
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd