Home › Device types › QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FDA product code QLG · Class 2 · Clinical Chemistry
72
Registered devices
165,465
Adverse events
10
Recalls
9
510(k) clearances
Devices with this code
Bigfoot Unity — Bigfoot Biomedical, Inc.FreeStyle Libre 2 — ABBOTT DIABETES CARE INCBigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.FreeStyle Libre 3 — ABBOTT DIABETES CARE INCBigfoot Unity — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.FreeStyle Libre 2 — ABBOTT DIABETES CARE INCFreeStyle Libre 3 — ABBOTT DIABETES CARE INCBigfoot Unity — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.Bigfoot Unity — Bigfoot Biomedical, Inc.FreeStyle Libre 2 — ABBOTT DIABETES CARE INCFreeStyle Libre 2 — ABBOTT DIABETES CARE INCBigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.FreeStyle Libre 2 — ABBOTT DIABETES CARE INCBigfoot Unity — Bigfoot Biomedical, Inc.FreeStyle Libre 3 App — ABBOTT DIABETES CARE INCBigfoot Unity — Bigfoot Biomedical, Inc.Bigfoot Unity Diabetes Management System — Bigfoot Biomedical, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-24 | Abbott Diabetes Care, Inc. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| 2025-11-24 | Abbott Diabetes Care, Inc. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| 2025-11-24 | Abbott Diabetes Care, Inc. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| 2025-11-24 | Abbott Diabetes Care, Inc. | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results |
| 2025-05-21 | BIGFOOT BIOMEDICAL | Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. |
| 2024-07-24 | Abbott Diabetes Care, Inc. | Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may |
| 2023-07-12 | Abbott Diabetes Care, Inc. | 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 displ |
| 2023-02-13 | Abbott Diabetes Care, Inc. | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with rea |
| 2023-02-09 | Abbott Diabetes Care, Inc. | 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 cou |
| 2021-03-16 | Cardinal Health Inc. | 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 in |
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