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Medical devices regulator issues alert on faulty glucose test strips

People with diabetes who use particular blood glucose test strips should stop using them and seek an alternative as soon as possible says the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a manufacturing fault which could lead to a risk of them giving false low blood glucose results.

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 high blood glucose (hyperglycaemia) which can have serious health implications.

People using these test strips, which are used in TRUEresult, TRUEresult twist, and TRUEtrack blood glucose meters, are asked to check if they use affected blood glucose test strips with the lot numbers below.

Product name Item number Lot number Exp. Date
TRUEresult PQQ E3I24‐81‐OTC PS2190IGB 31‐Dec‐17
TRUEresult PQQ E3I24‐81‐OTC PS2319IGB 18‐May‐18
TRUEresult PQQ E3I24‐81‐OTC PS2322IGB 19‐May‐18
TRUEresult PQQ E3I24‐81 PS2190IGB 31‐Dec‐17
TRUEresult PQQ E3I24‐81 PS2319IGB 18‐May‐18
TRUEresult PQQ E3I24‐81 PS2322IGB 19‐May‐18
TRUEresult PQQ E3I24‐81 PS2407IGB 16‐Jul‐18
TRUEtrack A3I24‐81 RS4645IGB 30‐Sep‐17


Product name Item number Kit lot number Exp. Date
TRUEresult PQQ E4I24‐81 KS1228 31‐Mar‐18
TRUEresult PQQ E4I24‐81 KS1229 31‐Mar‐18
TRUEresult PQQ E4I24‐81 KS1230 31‐Mar‐18
TRUEresult PQQ E4I24‐81 KS1241 31‐Mar‐18

MHRA has issued a Medical Device Alert (MDA) to healthcare professionals.

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 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.”

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