Home › Device types › PZI
Prescription Use Blood Glucose Meter For Near-Patient Testing
FDA product code PZI · Class 2 · Clinical Chemistry
10
Registered devices
191
Adverse events
6
Recalls
14
510(k) clearances
Devices with this code
STATSTRIP — NOVA BIOMEDICAL CORPORATIONAssure® Titanium Blood Glucose Test Strips — ARKRAY USA, INC.StatSensor StatStrip — NOVA BIOMEDICAL CORPORATIONSTATSTRIP — NOVA BIOMEDICAL CORPORATIONAssure® Titanium Blood Glucose Test Strips — ARKRAY USA, INC.StatSensor StatStrip — NOVA BIOMEDICAL CORPORATIONStatStrip — NOVA BIOMEDICAL CORPORATIONStatSensor StatStrip — NOVA BIOMEDICAL CORPORATIONAssure® Titanium Blood Glucose Meter — ARKRAY USA, INC.STATSTRIP — NOVA BIOMEDICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-29 | Nova Biomedical Corporation | A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previous |
| 2026-07-29 | Nova Biomedical Corporation | A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previous |
| 2026-07-29 | Nova Biomedical Corporation | A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previous |
| 2026-07-29 | Nova Biomedical Corporation | A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previous |
| 2026-07-29 | Nova Biomedical Corporation | A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previous |
| 2024-11-20 | Nova Biomedical Corporation | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's |
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