FreeStyle Libre 3 Plus Continuous Glucose Monitoring System (Sensor Kit)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• 4 recalls, same reason

  • Ongoing Z-1021-2026 FDA Class I ·initiated 24 Nov 2025 ·on shared 510(k) K233537
  • Ongoing Z-1020-2026 FDA Class I ·initiated 24 Nov 2025 ·on shared 510(k) K212132
  • Ongoing Z-1022-2026 FDA Class I ·initiated 24 Nov 2025 ·on shared 510(k) K233537
  • Ongoing Z-1023-2026 FDA Class I ·initiated 24 Nov 2025 ·on shared 510(k) K212132

  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

• • Ongoing Z-2692-2024 FDA Class I ·initiated 24 Jul 2024 ·on shared 510(k) K212132

  Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.

• • Completed Z-0734-2024 FDA Class II ·initiated 9 Feb 2023 ·on shared 510(k) K213996

  If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high glucose, which could result in delayed treatment: not taking insulin (for high glucose), or not taking glucose (for low glucose) when required.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Full name

FreeStyle Libre 3 Plus Continuous Glucose Monitoring System

Trade Name

FreeStyle Libre 3 Plus Continuous Glucose Monitoring System

FreeStyle LIbre 3 Continuous Glucose Monitoring System

Device Name

FreeStyle Libre 3 Continuous Glucose Monitoring System (Reader Kit)

Model / Reference

78788-01, 78880-02, 78795-02, 72239-02, 72233-02, 72238-02

Primary DI / UDI-DI

05021791007257, 05021791009350, 05021791009251, 05021791009336, 05021791009329, 05021791009299

Basic UDI-DI

5021791FLS0003E3, 5021791FLR0003DQ

Direct Marketing DI

05021791012022

05021791011995

05021791011964

05021791011988

EMDN Code

Z1204011585, Z1204011501

Device Class

Class IIb

EU market of registration

Belgium

Denmark

Netherlands

Ireland

Spain

EUDAMED SRN

GB-MF-000029309

Authorised representative

Abbott B.V. NL-AR-000012577

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See all devices from Abbott Diabetes Care Ltd →

• What types of sensors are included in the FreeStyle Libre 3 Plus Continuous Glucose Monitoring System, and how do they differ from each other?

  The FreeStyle Libre 3 Plus system includes two sensor types: the Instinct sensor and the Instinct Go sensor. Both are designed for real-time, non-invasive glucose monitoring over a 14-day period, but they may differ in features like ease of use, scanning technology, or additional functionalities (e.g., alerts or trend analysis). The system is supplied as a single-use, sterile sensor kit (Reference: 78788-01) for subcutaneous application, ensuring no reuse or implantation.

• Is the FreeStyle Libre 3 Plus sensor reusable, and if not, how should it be disposed of after use?

  No, the FreeStyle Libre 3 Plus sensor kit (Reference: 78788-01) is explicitly designed for single-use only and is not intended for reuse. After use, the sensor should be removed and disposed of according to local medical waste guidelines, as it is not intended for reprocessing or reuse.

• How should the FreeStyle Libre 3 Plus sensor be stored before use, and is it sterile?

  The FreeStyle Libre 3 Plus sensor is supplied in a sterile container (Primary DI: 05021791007257) to maintain sterility until use. It should be stored as directed by the manufacturer, typically in a cool, dry place away from direct sunlight, and used immediately after opening to preserve sterility. The packaging ensures no contamination before application.

• What regulatory pathways does the FreeStyle Libre 3 Plus Continuous Glucose Monitoring System follow, and how does this affect its availability?

  The FreeStyle Libre 3 Plus system is authorized under FDA 510K and MDR (Medical Device Regulation) pathways, confirming compliance with U.S. and EU regulatory standards. This approval ensures traceability through a Basic UDI (5021791FLS0003E3) and supports its distribution in markets adhering to these frameworks. Availability depends on local regulatory acceptance and market-specific compliance.

• Are there any latex components or medicinal product interactions associated with the FreeStyle Libre 3 Plus sensor?

  No, the FreeStyle Libre 3 Plus sensor does not contain latex components and is not intended for use with medicinal products or animal/human tissues. It is designed solely for subcutaneous glucose monitoring, ensuring compatibility with standard diabetes management practices without cross-contamination risks.