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FDA Issues Alert: Abbott Glucose Monitors Linked to Deaths

12/4/2025

Summary

Story summary

Abbott Diabetes Care's glucose monitors have been associated with seven deaths and over 700 serious injuries worldwide due to inaccurate readings.
The U.S. Food and Drug Administration (FDA) issued a safety alert on December 2, 2025, concerning about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
Abbott stated that faulty sensors may yield dangerously low glucose readings, prompting incorrect treatment decisions.
Users should verify their sensor serial numbers and stop using affected models immediately.
Abbott has addressed the manufacturing issue and will offer free replacements.

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Story summary

Abbott Diabetes Care's glucose monitors have been associated with seven deaths and over 700 serious injuries worldwide due to inaccurate readings.
The U.S. Food and Drug Administration (FDA) issued a safety alert on December 2, 2025, concerning about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors.
Abbott stated that faulty sensors may yield dangerously low glucose readings, prompting incorrect treatment decisions.
Users should verify their sensor serial numbers and stop using affected models immediately.
Abbott has addressed the manufacturing issue and will offer free replacements.