Abbott Recalls 500,000 Glucose Monitors After Inaccurate Readings

Abbott Laboratories has recalled 500,000 FreeStyle Libre 3 continuous glucose monitors after discovering a software bug that can produce falsely low readings, potentially leading diabetic patients to skip necessary insulin doses.

The Issue

A firmware error in specific manufacturing lots causes the sensor to report blood glucose levels 15-30% lower than actual values under certain conditions, particularly in high-humidity environments.

Patient Advisory

The FDA has classified this as a Class I recall — the most serious category — and urges affected patients to verify readings with finger-prick tests until they receive replacement sensors.

• 500,000 FreeStyle Libre 3 sensors recalled
• Class I recall — most serious FDA category
• Readings can be 15-30% too low
• Verify with finger-prick tests immediately