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FDA warns FreeStyle Libre 3/Plus sensors may give falsely low glucose readings, causing serious harm; 736 injuries and 7 deaths reported.
The FDA has issued an early alert about certain FreeStyle Libre 3 and Libre Plus glucose sensors that may give falsely low readings, potentially leading to dangerous treatment errors like excessive carb intake or delayed insulin.
As of November 14, 2025, the agency reported 736 serious injuries and seven deaths linked to the issue.
Affected sensors have specific model numbers and serial codes; readers, apps, and other Abbott devices are not impacted.
Users are urged to stop using affected sensors, dispose of them, and request replacements via the FreeStyle Check website.
The FDA recommends verifying readings with a blood glucose meter if symptoms don’t match sensor data.
La FDA advierte que los sensores FreeStyle Libre 3/Plus pueden dar falsas lecturas de glucosa baja, causando graves daños; 736 lesiones y 7 muertes reportadas.