The MHRA have issued an alert for blood glucose test strips for use in TRUEresult, TRUEresult twist, and TRUEtrack blood glucose meters.
A list of the affected strips can be found onthe MHRA website.
People with diabetes should check this list of batch numbers, and if they are affected, stop using them and seek an alternative as soon as possible.
The manufacturer, Nipro Diagnostics, found an issue with the packaging meaning that test strips in specific lots are not sealed properly. This can affect how the strips measure blood glucose levels and could lead to undetected hyperglycaemia.
‘Important that you check your test strips’
John Wilkinson, MHRA’s Director of Medical Devices said: “It’s important that you check your test strips. Stop using them if they are in the affected lots and, if necessary, seek alternatives as soon as possible. You can contact the manufacturer on 0800 08 588 08 to return affected strips.
“If you have any questions about your blood glucose readings you should speak with your diabetes care team.
“We continue to encourage people to report any issues involving medical devices to MHRA via our Yellow Card Scheme.”
Simon O’Neill, Director of Health Intelligence and Professional Liaison at Diabetes UK said:
“Ensuring the correct level of blood sugar is vitally important in the management of diabetes.
“We welcome this action taken by MHRA to ensure people can be sure of correctly testing their blood glucose.
“People using these test strips should return them to the manufacturer. If they have any concerns about their blood sugar levels they should talk to their diabetes care team.”