Around 1.7 million blood glucose test strips in the UK are being recalled due to concerns over potential false readings.
The Medicines and Healthcare Regulatory Agency (MHRA) issued a Medical Device Alert on Wednesday which warned that two affected lots of the GlucoMen LX Sensor diabetes test strips (for use with the GlucoMen LX and GlucoMen LX PLUS blood glucose meter), were contaminated during production.
Sold in the UK between October and November 2012, the test strips may give an overestimation of blood glucose levels, which could lead to inappropriate insulin doses being administered.
Affected test strips include products with the following lot numbers:
• Lot 3212219249, expiry date 31-08-2014
• Lot 3212214249, expiry date 31-08-2014
Diabetic patients who find they have a faulty test strip are being advised by the MHRA to avoid using it and seek advice on alternative test strips by contacting their GP or diabetes clinic.
John Wilkinso, the MHRA’s Director of Medical Devices, said: “People who have GlucoMen LX Sensor blood glucose test strips from these specific lots at home should not use them.”
“The manufacturing fault in these test strips could give a misleading reading that may result in people overestimating the amount of insulin they need to take.”
“The fault has been resolved and the two affected lots of faulty test strips have not been sold in the UK since November 2012,” he said, adding that there is currently “no evidence that any patients in the UK have been adversely affected”.
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