StatStrip Glucose Ketone Hospital Meter System — Class I medical device recall Z-0682-2025
Ongoing recall by Nova Biomedical Corporation, reported 2025-01-01, distributed nationwide. A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test
| Recall number | Z-0682-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Biomedical Corporation, Waltham, MA, United States |
| Recall initiated | 2024-11-20 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, DE, GB, IL, IT, NL |
| Quantity | 347 units |
| Reason classes | software |
| Model numbers | 63683 |
Product
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Reason for recall
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0682-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.