FreeStyle Libre 2
The FreeStyle Libre 2 sensor is the wearable component of an integrated glucose-monitoring system. An adhesive pad holds the sensor on the back of the upper arm, with a small sensor tail…
The FreeStyle Libre 2 sensor is the wearable component of an integrated glucose-monitoring system. An adhesive pad holds the sensor on the back of the upper arm, with a small sensor tail beneath the skin measuring glucose in interstitial fluid.
Its glucose oxidase enzyme generates an electrical current proportional to glucose concentration. The system converts that current to a glucose value. The disposable sensor measures every minute, stores eight hours of data and is factory calibrated for wear up to 14 days.
Listed Item
FreeStyle Libre 2 Flash Glucose Monitoring System Sensor
Reader and Wireless Functions
The reader scans the sensor by RFID to display the current glucose value, trend arrow and historical graph. Bluetooth Low Energy supports configurable low-glucose, high-glucose and signal-loss alarms. The sensor and reader work together; this version of the system is not compatible with automated insulin-delivery or insulin-suspend systems.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Abbott Diabetes Care Limited, United Kingdom |
|---|---|
| FDA product code | QLG |
| Device type | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1355 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K193371 |
| Record published | 2020-07-31 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 36 to 82 °F; Storage environment humidity 10 to 90 % RH |
| Packaging | Case, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71992 | In distribution | |
| 71951 | In distribution | |
| 72000 | In distribution | |
| 71951 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | 39 |
| Bigfoot Unity | Bigfoot Biomedical, Inc. | 15 |
| FreeStyle Libre 3 | Abbott Diabetes Care Limited | 2 |
| FreeStyle Libre 3 App | Abbott Diabetes Care Limited | 2 |
| Libre App | Abbott Diabetes Care Limited | 1 |
| FreeStyle Libre 2 App | Abbott Diabetes Care Limited | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223537 | 2023-02-21 |
| K212132 | 2022-05-26 |
| K213996 | 2022-05-26 |
| K210943 | 2021-11-22 |
| K211102 | 2021-08-11 |
| K201761 | 2021-07-30 |
| K193371 | 2020-06-12 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Diabetes Care Limited | 510(k) number | 2023-07-12 | Class II | Software Design Change | If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn’t used for the full 14-day wear time, then the reader may display “Incompatible Sensor” message. If users don’t have the previous sensor, or Fr | 1,722,645 |
| Abbott Diabetes Care Limited | 510(k) number | 2023-02-13 | Class I | Device Design | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it | 1,534,532 |
| Cardinal Health | 510(k) number | 2021-03-16 | Class II | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. | 2,115 kits |
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-11-24 | Class I | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | 1,060,723 sensors |
| 2025-11-24 | Class I | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | 258,913 sensors |
| 2025-11-24 | Class I | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | 1,663,241 sensors |
| 2025-11-24 | Class I | Process control | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | 8,062 sensors |
| 2024-07-24 | Class I | Process design | 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 inacc | 8,174 |
| 2023-02-09 | Class II | Software design | 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 undetec | 45,173 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.