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Assure® Titanium Blood Glucose Meter
ARKRAY USA, INC. · Model 600001 · UDI-DI 00015482600013
PZI
Prescription
1
510(k) clearances
191
Adverse events (5 deaths)
6
Recalls
8
Facilities
Description
The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium Blood Glucose Test Strips and Assure Control-Control Solutions are not included in the kit package and should be purchased separately.
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 previously scanned barcode |
| 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 previously scanned barcode |
| 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 previously scanned barcode |
| 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 previously scanned barcode |
| 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 previously scanned barcode |
| 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 data management syst |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.