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