Events

Safety Alert for HemoCue Glucose 201 Microcuvettes single packed

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by HemoCue AB.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-11-12
  • Event Date Posted
    2014-11-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141112.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hemocue glucose 201 microcuvettes single packed the australia therapeutic goods administration (tga) posted a medical device safety alert concerning hemocue glucose 201 microcuvettes single packed manufactured by hemocue ab. the affected article number is 110718 and the affected lot number is 1310798. the manufacturer has become aware that the hemocue glucose 201 microcuvette 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. according to the manufacturer, the microcuvettes of this specific lot number have now passed their expiry date and should have been used, or be discarded. the manufacturer recommends users that the need for repeat testing be determined by the laboratory or clinical director. for details, please refer to the following link: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2014-rn-01197-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 november 2014.

Device

HemoCue Glucose 201 Microcuvettes single packed
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: HemoCue Glucose 201 Microcuvettes single packed
  • Manufacturer
    HemoCue AB

Manufacturer

HemoCue AB