Events

Recall of HemoCue HbA1c 501 Test Cartridge. 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-2015-RN-01115-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01115-1
  • 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 manufacturer has advised that some of the hba1c501 test cartridges may give elevated results. as the hba1c501 is used to provide the average glucose concentration over a period of time for patient management and not immediate treatment, an elevated result would not impact patient management.
  • Action
    Radiometer is advising users to discard any remaining stock. This action has been closed-out on 18/08/2016.

Device

HemoCue HbA1c 501 Test Cartridge. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    HemoCue HbA1c 501 Test Cartridge. An in vitro diagnostic medical device (IVD)Lot Number: F14K12K21DLARTG Number: 206986
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd