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FDA Raises Alarm: Abbott’s FreeStyle Libre 3 Recalled After Linking to 7 Deaths
The FDA has upgraded its recall of select Abbott FreeStyle Libre 3 and 3 Plus continuous glucose monitors (CGMs) to Class I – its most urgent warning level. This alert comes after reports of these medical wearables displaying dangerously inaccurate low glucose readings, potentially contributing to 860 serious injuries and seven fatalities.
Abbott first notified users about the sensor malfunction in November through direct letters. The FDA followed with a December safety notice before escalating to the current Class I designation – a critical development for users of these health monitoring wearables.
What Went Wrong With These Smart Wearables?
Investigations traced the failure to a specific production line where sensors consistently underreported blood glucose levels. For diabetes patients relying on these phone-free wearables, false low readings could trigger disastrous decisions like insulin reduction or excessive carb consumption – potentially causing life-threatening hyperglycemia.
This incident underscores why accuracy remains paramount in medical wearables, much like how fall detection wearables must reliably sense emergencies. While Abbott confirms resolution of the manufacturing flaw, affected users face immediate risks.
Is Your CGM Part of the Recall?
The recall impacts specific batches of both FreeStyle Libre 3 and Libre 3 Plus sensors. Users should:
- Check serial numbers (found in the app, reader, or packaging)
- Visit Abbott’s recall verification portal
If your sensor is affected, remove it immediately and switch to traditional glucose testing. Abbott is providing free replacements. During transitions, users might consider backup monitoring options like eSIM smartwatches with health tracking capabilities.
Why This Matters for Wearable Tech Users
As smart wearables become essential health tools, rigorous safety standards grow increasingly vital. This recall serves as a crucial reminder to:
- Regularly check FDA alerts for medical devices
- Maintain backup monitoring methods
- Verify wearable accuracy against traditional methods periodically
Stay tuned to Unpocket for ongoing coverage of prescription smart glasses, eSIM-enabled wearables, and innovations creating safer phone-free lifestyles. Our expert team vets all tech to ensure your health data remains reliable.
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