Recall Z-1023-2026— Abbott Diabetes Care, Inc.
Class I · Ongoing
Class I FDA medical device recall by Abbott Diabetes Care, Inc., initiated 2025-11-24. It names one FDA 510(k) clearance: K212132. Product: FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.. Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results.
- Recalling firm
- Abbott Diabetes Care, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-11-24
- Firm location
- Alameda, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.