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Safety alert issued on faulty glucose test strips

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Patients with diabetes who use blood glucose test strips from a particular product range should be told to stop using them and seek an alternative as soon as possible, a safety watchdog has warned.

The Medicines and Healthcare products Regulatory Agency issued a device alert in response to a manufacturing fault that could lead to a risk of the devices 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 hyperglycaemia, noted the MHRA.

Simon O’Neill, director of health intelligence at Diabetes UK said: “We welcome this action taken by MHRA to ensure people can be sure of correctly testing their blood glucose.”

The affected test strips, which are used in TRUEresult, TRUEresult twist, and TRUEtrack blood glucose meters, have the following lot numbers.

Product NameItem NumberLot numberExp. 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 NameItem NumberKit Lot numberExp. 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

 

 

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