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StatSensor StatStrip
NOVA BIOMEDICAL CORPORATION · Model Gen 2.0 · UDI-DI 00385480667685
1
510(k) clearances
191
Adverse events (5 deaths)
6
Recalls
8
Facilities
Description
StatSensor StatStrip Docking Station (Quad Bay)
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.