Events

Safety Alert for HemoCue HbA1c 501 Test Cartridges

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

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
    2015-11-25
  • Event Date Posted
    2015-11-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151125b.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: infopia hemocue hba1c 501 test cartridges the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning hemocue hba1c 501 test cartridges, manufactured by infopia. the affected products were manufactured in november 2014 with model number 405110 and lot number f14k12k21dl. according to the manufacturer, in some cases the affected product gives elevated results. the manufacturer is advising users not to use the test cartridges from this lot and to discard any remaining stock. for details, please refer to the mhra website: https://mhra.Filecamp.Com/public/file/2bw2-d0857bhd according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 november 2015.

Device

HemoCue HbA1c 501 Test Cartridges
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Infopia HemoCue HbA1c 501 Test Cartridges
  • Manufacturer
    Infopia

Manufacturer

Infopia