FDA Device recall Z-0682-2025
StatStrip Glucose Ketone 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 Ketone Hospital Meter System by Nova Biomedical, citing 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) a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0682-2025 |
| 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 Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Reason
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.
Identifiers
| code_info | Model No 63683. UDI-DI (01)38548063685. 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-0682-2025%22
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