StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
FDA Device Recall #Z-3129-2026 - Class I, July 29, 2026
Recall Summary
| Recall Number | Z-3129-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | July 29, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nova Biomedical Corporation |
| Location | Waltham, MA |
| Product Type | Devices |
| Quantity | 10,941 units |
Product Description
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Dominican Rep., Finland, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Korea, Switzerland, Thailand, Turkey, United Kingdom.
Lot / Code Information
Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
Other Recalls from Nova Biomedical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3128-2026 | Class I | StatStrip Glucose Hospital Meter System. Model ... | Jul 29, 2026 |
| Z-3131-2026 | Class I | StatStrip Glucose and B- Ketone meter. Model No... | Jul 29, 2026 |
| Z-3132-2026 | Class I | StatStrip Glucose and B- Ketone meter. Model No... | Jul 29, 2026 |
| Z-3130-2026 | Class I | StatStrip Glucose and B- Ketone meter. Model No... | Jul 29, 2026 |
| Z-0682-2025 | Class I | StatStrip Glucose Ketone Hospital Meter System.... | Nov 20, 2024 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.