FreeStyle Libre 3 Sensors Recalled

Martin Murphy·
Medication and Product InfoNews

A safety alert has been issued for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors following findings that some units may produce incorrect low blood glucose readings. The manufacturer has initiated corrective action for affected batches.

What the Issue Is
  • A manufacturing problem on one production line has resulted in some Libre 3 and Libre 3 Plus sensors providing falsely low glucose readings.
  • Incorrect readings can cause inappropriate treatment decisions such as missed insulin doses or excessive carbohydrate intake.
  • There have been 736 reports of severe adverse events linked to this fault in global data, including seven deaths. None have been confirmed in the UK.
  • Other Libre models, readers and the associated app are not affected.
Who Is Affected
  • The recall applies only to specific Libre 3 and Libre 3 Plus sensors from the affected production line.
  • Patients can check whether their sensor is part of the recall by entering the serial number into the manufacturer’s online checker.
What Pharmacies and Healthcare Professionals Should Do
  • Alert patients who use Libre 3 or Libre 3 Plus sensors and encourage them to check their serial numbers.
  • Provide guidance on alternative blood glucose monitoring options for those who are affected.
  • Check any stock in the pharmacy and remove affected items from use until replacements arrive.
  • Report adverse events or suspected device problems through the appropriate national reporting scheme.
What Patients Should Do
  1. Check the sensor serial number at the dedicated recall website.
  2. If the sensor is listed as affected, stop using it immediately and dispose of it safely.
  3. Switch to a validated alternative blood glucose testing method until a replacement sensor is received. This may include a finger prick meter or the meter built into certain Libre readers.
  4. If glucose readings from a sensor do not match how the person feels, a confirmatory finger prick test should be carried out.
Replacement Information
  • The manufacturer will supply replacement sensors free of charge for those affected.
  • Sensors and devices not included in the recall remain suitable for continued use.