Events

Recall of HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care 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 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-2012-RN-00749-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-07-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00749-3
  • 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 of indications of in-correct high readings of hemocue glucose 201 rt and hemocue glucose 201 dm rt for the application of monitoring of blood glucose levels on pre-term neonates. on full-term neonates there are no similar indications but as a precaution hemocue has decided to replace all systems on delivery and neonatal wards with hemocue glucose 201+ or hemocue glucose 201 dm while investigations continue.
  • Action
    HemoCue is recalling affected devices and is replacing them with unaffected models

Device

HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care in vitro diagnostic medical device ...
  • Model / Serial
    HemoCue Glucose 201 RT and 201 DM RT Systems. A point of care in vitro diagnostic medical device (IVD). Affected Product Numbers: 124713 and 124013
  • Manufacturer
    HemoCue Australia Pty Ltd

Manufacturer

HemoCue Australia Pty Ltd
  • Source
    DHTGA