Safety Alert for PTS Panels Glucose Test Strips

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

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
    2013-04-24
  • Event Country
  • Event Source
    DH
  • 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 pts panels glucose test strips (with photo) the department of health (dh) today (april 23) directs a local medical device supplier, lynx technology limited (lynx) to recall one lot of the pts panels glucose test strips from consumers as the test strips may give falsely low blood glucose readings. the dh noticed through its surveillance of medical devices that the product's manufacturer, polymer technology systems, inc., has discovered through its product performance surveillance that one lot of the product (lot number: u117) showed falsely low blood glucose readings. a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. according to lynx, some 100 bottles of the affected lot of glucose test strips have been imported into hong kong and distributed to pharmaceutical companies, medical equipment companies and non-governmental organisations, etc. "so far, the dh has not received any local report of adverse events arising from use of the product," the spokesman said. members of the public who may have the affected lot of the test strips in their possession are advised to stop using the product and return their remaining inventory to the local supplier. lynx has set up a hotline 2568 1268 to answer public enquiries on recall arrangements. "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 added. the dh has informed relevant stakeholders about the recall and shall continue to liaise with the supplier on the follow-up actions. ends.

Device

  • Model / Serial
  • Product Description
    Press release: Recall of PTS Panels Glucose Test Strips (with photo)
  • Manufacturer

Manufacturer