Safety Alert for EUKARE Blood Glucose Test Strip

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Eumed Biotechnology Co. Ltd..

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
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Press release
  • Reason
    Recall of eukare blood glucose test strip the department of health (dh) today (march 5) drew public attention to the recall of certain lots of a blood glucose test strip, the eukare blood glucose test strip. the affected test strips may give falsely high blood glucose readings. the dh noticed through its surveillance of medical devices that the product's manufacturer, eumed biotechnology co. ltd., has recalled two lots of the products (lot numbers: ts14dd1f1002 and ts16dd1h2814). information from the manufacturer indicates that the problem appears to be related to improper storage of a reagent of the test strips. a spokesman for the dh explained that falsely high blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hypoglycaemia. according to the manufacturer, the eukare blood glucose test strip has not been imported into hong kong. so far, the dh has not received any local report of adverse events arising from use of the product. "though the affected product has not been introduced into the hong kong market, and we have no record of related adverse events here, the possibility of individual diabetic patients having somehow obtained the product from abroad justifies a public alert, in our opinion," the spokesman said. members of the public who may have the above test strips in their possession are advised to stop using the product and surrender them to the dh's medical device control office at room 3101, 31/f, hopewell centre, 183 queen's road east, wan chai. "for those customers who have used the said product and are either feeling unwell or in doubt, they should consult their health-care professionals for advice as soon as possible," the spokesman said. ends.