Events

Recall of HemoCue Glucose 201 Microcuvettes single packed

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by HemoCue 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-2014-RN-01197-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01197-1
  • 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
    Hemocue has become aware that the hemocue glucose 201 microcuvette (lot number110718) may, at the end of their shelf-life, yield measurements higher than expected. the higher glucose values may have led to unnecessary insulin treatment or lack of glucose treatment.
  • Action
    The microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. It is recommended that the need for repeat testing be determined by the laboratory or clinical director. This action has been clsoed-out on 22/08/2016.

Device

HemoCue Glucose 201 Microcuvettes single packed

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA