Home › Device types › NBW
System, Test, Blood Glucose, Over The Counter
FDA product code NBW · Class 2 · Clinical Chemistry
1,501
Registered devices
431,358
Adverse events
137
Recalls
509
510(k) clearances
Devices with this code
LEADER — Cardinal Health 110, Inc.ReliOn® micro Blood Glucose Monitoring System — WAL-MART STORES, INC.TRUE METRIX — TRIVIDIA HEALTH, INC.GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM — GENESIS HEALTH TECHNOLOGIES, LLCCONTOUR® NEXT LINK — ASCENSIA DIABETES CARE US INC.RELION — WAL-MART STORES, INC.Assure® Prism Multi Blood Glucose Meter — ARKRAY USA, INC.GoChek2 — Microtech Medical (Hangzhou) Co., Ltd.SMARTMETER — BIONIME CORPORATIONTyson Bio HT100-B Blood Glucose Monitoring System — TYSON BIORESEARCH INC.keto mojo glucose test strips (50pcs/box) — KETO-CHECK, INC.Accu-Chek Inform II Base Unit Light — Roche Diagnostics GmbHRightest — BIONIME CORPORATIONAUVON — UAN HEALTHCARE LIMITEDCURO L5 Total Cholesterol Strips — KPI HEALTHCARE, INC.EZ Smart-608 Blood Glucose Test Strips (50T) — TYSON BIORESEARCH INC.Tyson Bio HS100 Blood Glucose Meter — TYSON BIORESEARCH INC.GLUCOCARD® Shine Blood Glucose Monitoring System — ARKRAY USA, INC.GlucoTrack VOICE Blood Glucose Monitoring System — PHILOSYS Co., LtdeGLU, 15ct., CCPlus Home — POLYMER TECHNOLOGY SYSTEMS, INC.VivaGuard Ino Smart Blood Glucose Meter — ABOUND Diagnostics, Inc.Rightest — BIONIME CORPORATIONAUVON — Shenzhen Yuwen E-Commerce Co., Ltd.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description |
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description |
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description |
| 2026-02-06 | Trividia Health, Inc. | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description |
| 2025-10-07 | Trividia Health, Inc. | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to |
| 2025-01-30 | Telcare, LLC | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monit |
| 2024-05-13 | Roche Diabetes Care, Inc. | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may su |
| 2023-05-19 | Ascensia Diabetes Care US, Inc. | Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among |
| 2022-06-21 | Touch US Llc | Device was marketed without FDA 510(k) clearance or a PMA. |
| 2021-07-28 | Roche Diabetes Care, Inc. | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and |
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