Home › Device types › QBJ
Integrated Continuous Glucose Monitoring System, Factory Calibrated
FDA product code QBJ · Class 2 · Clinical Chemistry
74
Registered devices
2,174,187
Adverse events
23
Recalls
18
510(k) clearances
Devices with this code
Dexcom G7 Android App — Dexcom, Inc.Dexcom G7 Sample Pack (160) — Dexcom, Inc.Dexcom G7 GSS (160) — Dexcom, Inc.Dexcom G7 GSS (161) — Dexcom, Inc.Dexcom G6 Sensor Applicator Assembly — Dexcom, Inc.FreeStyle Libre 3 Plus — ABBOTT DIABETES CARE INCDexcom G6 Receiver — Dexcom, Inc.Dexcom G6 Transmitter — Dexcom, Inc.FreeStyle Libre 3 — ABBOTT DIABETES CARE INCDexcom G6 Sensor Kit (1) Medicare — Dexcom, Inc.Dexcom G7 GSS (161) — Dexcom, Inc.US G6 Pro Reader Kit — Dexcom, Inc.Dexcom G7 Receiver — Dexcom, Inc.Dexcom G7 GSS — Dexcom, Inc.FreeStyle Libre 2 Plus — ABBOTT DIABETES CARE INCFreeStyle Libre 3 Plus — ABBOTT DIABETES CARE INCFreeStyle Libre 3 — ABBOTT DIABETES CARE INCDexcom G6 Android — Dexcom, Inc.Dexcom G7 GSS (160) — Dexcom, Inc.Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System — Dexcom, Inc.G6 Sample Sensor/Transmitter Kit — Dexcom, Inc.Dexcom G7 GSS — Dexcom, Inc.Dexcom G7 GSS (160) — Dexcom, Inc.Dexcom G6 Receiver — Dexcom, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-27 | Dexcom, Inc. | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were late |
| 2026-04-14 | Dexcom, Inc. | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend |
| 2026-04-14 | Dexcom, Inc. | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend |
| 2026-04-14 | Dexcom, Inc. | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-08-28 | Dexcom, Inc. | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glu |
| 2025-07-24 | Dexcom, Inc. | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) |
| 2025-07-24 | Dexcom, Inc. | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) |
| 2025-07-24 | Dexcom, Inc. | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) |
| 2025-07-24 | Dexcom, Inc. | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.