FDA Device recall Z-0681-2025
StatStrip Glucose Hospital Meter System
- FDA Device
- Class I
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class I recall of StatStrip Glucose Hospital Meter System by Nova Biomedical, citing 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 sys….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0681-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-11-20 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nova Biomedical |
| Distribution | US |
Product
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Reason
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 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 glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Identifiers
| code_info | Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0681-2025%22
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