FDA-Device2026-01-21Class IPROCESSING DEFECT
Abbott FreeStyle Libre 3 Plus Sensor recalled for potential incorrect low glucose readings
What this means
Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup could result in the sensor showing incorrect low blood sugar readings when your actual glucose is normal or high.
- Check if your sensor's serial number matches the recalled list on Abbott's website or FDA notice
- Stop using any recalled sensor immediately
- Switch to an alternative glucose monitoring method until you receive a replacement
- Contact Abbott customer service for a free replacement sensor
- Speak with your doctor if you need temporary guidance on glucose monitoring
The agency's original wording
Hazard
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.: AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WI, WV, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Marino, Spain, Sweden, Switzerland, and United Kingdom.
Affected count
1,663,241 sensors
Manufactured in
1360 S Loop Rd, Alameda, CA, United States
Products
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1021-2026Want us to check the next one for you?
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