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Diabetes test strip warning issued by MHRA

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Patients with diabetes are being advised to check if they have certain lot numbers of a specific type of blood glucose test strip that has been affected by a manufacturing fault.

Some of the test strips may give inaccurate readings because of the fault, according to a warning issued by the Medicines and Healthcare products Regulatory Agency.

Three lots of Freestyle Lite Blood Glucose Test Strips are affected – numbers 1284962, 1366626 and 1372611. However, the issue only occurs when they are used with the following home monitoring meters:

  • FreeStyle Blood Glucose Meters (manufactured by Abbott)
  • FreeStyle Mini Blood Glucose Meters (Abbott) FreeStyle Navigator (Abbott)
  • FreeStyle meter built into the Omnipod Insulin Management System (manufactured by Insulet Corporation).

Around 15,000 of these meters in the UK use the Freestyle Lite Blood Glucose Test Strips, according to the MHRA.

Abbott Diabetes Care has already to clinicians about the problem and patients are advised to contact customer services on 0800 072 1020 for free replacement test strips. 

MHRA director of medical devices John Wilkinson said:  “While three lots of the test strips have been affected by the manufacturing fault this problem has been resolved and there is no evidence that any patients in the UK have been adversely affected by the faulty test strips.”

The issue does not occur when the affected test strips are used with newer meter brands, such as FreeStyle Lite Blood Glucose Meters, FreeStyle Freedom Lite Blood Glucose Meters, FreeStyle Insulinx Blood Glucose Meters and FreeStyle Navigator II. 


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