FDA Device recall Z-3132-2026
StatStrip Glucose and B- Ketone meter
- FDA Device
- Class I
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class I recall of StatStrip Glucose and B- Ketone meter by Nova Biomedical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3132-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-07-29 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Nova Biomedical |
| Distribution | US |
Product
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Reason
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 including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.
Identifiers
| code_info | Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Nova Biomedical
- StatStrip Glucose Hospital Meter System
FDA Device · Class I · 2026-09-23 · Nova Biomedical - StatStrip Glucose and B- Ketone meter
FDA Device · Class I · 2026-09-23 · Nova Biomedical - StatStrip Glucose Hospital Meter System
FDA Device · Class I · 2026-09-23 · Nova Biomedical - StatStrip Glucose and B- Ketone meter
FDA Device · Class I · 2026-09-23 · Nova Biomedical - StatStrip Glucose Ketone (mmol/L) Hospital Meter System
FDA Device · Class I · 2025-01-01 · Nova Biomedical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3132-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.