Events

Safety Alert for TRUEtrack and TRUEtest Blood Glucose Test Strips

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

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
    2016-07-20
  • Event Date Posted
    2016-07-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160720.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: truetrack and truetest blood glucose test strips the health canada has posted a medical device safety alert concerning the truetrack and truetest blood glucose test strips, manufactured by trividia health, inc. the model and lot numbers affected by this issue are described below: truetrack blood glucose test strips [model number: a3i20-80, a3i20-81; lot number: rs4567ica, rs4704ica] truetest blood glucose test strips [model number: e3i20-80, e3i20-81; lot number: ps2284ica, ps2316ica, ps2335ica] a limited number of sealed test strip vial boxes from certain blood glucose test strip lots may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can affect strip performance. in particular, test strips exposed to the environment may provide incorrect low blood glucose results. according to the manufacturer, inaccurate low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment. for details, please refer to the health canada’s websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59384r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 july 2016.

Device

TRUEtrack and TRUEtest Blood Glucose Test Strips
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: TRUEtrack and TRUEtest Blood Glucose Test Strips
  • Manufacturer
    Trividia Health

Manufacturer

Trividia Health