Events

Recall of HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)

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-2013-RN-00279-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00279-1
  • 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
    During extended investigations on neonates it was confirmed that hemocue glucose 201 rt and hemocue glucose 201 dm rt perform according to specifications in all neonatal settings except neonatal intensive care. critically ill neonates in intensive care settings often have immature metabolism in combination with complex treatment. this setting has not been fully evaluated for hemocue glucose 201 rt and glucose 201 dm rt. incorrect readings may lead to indirect harm to patients such as misdiagnosis or inappropriate treatment. therefore the following text will be added to the intended use: "the system should not be used on critically ill neonates in neonatal intensive care settings".
  • Action
    HemoCue is enclosing adhesive labels with the updated intended use along with the customer letters so that end users can use this to cover the current intended use in the Operating Manual, Technical Specifications etc.

Device

HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD)...
  • Model / Serial
    HemoCue Glucose 201 RT and Glucose 201 DM RT Systems (An in vitro diagnostic medical device (IVD) for the quantitative detection of blood glucose)
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA