Recall Z-1021-2026 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Abbott Diabetes Care, Inc.
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.
| Date | Jan 14, 2026 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| Reason | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| Root cause | Process control |
| Action | On 11/24/2025, the firm communicated "Urgent Medical Device Correction" letter to customers and Healthcare Providers that Abbott has recently identified that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. We learned about this through our ongoing product monitoring, where Libre 3 and Libre 3 Plus sensor users reported situations where they received incorrect low glucose readings. Customers are instructed: -If you are currently wearing or have a FreeStyle Libre 3 / FreeStyle Libre 3 Plus sensor that has been confirmed as potentially affecte |
| Quantity | 1,663,241 sensors |
| 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, and WY. O.U.S.: Andorra, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, New Zealand, Norway, Qatar, San Mar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System Abbott Diabetes Care, Inc., Apr 23, 2024 |