Abbott Diabetes Care, Inc.
Device Recalls (Class I)
Class I
Z-1022-2026
·
20260121
·
Ongoing
Product
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Reason for Recall
Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
Distribution
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, a...
Source: openFDA Enforcement API