StatStrip Glucose and B- Ketone meter
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.
- Agency
- FDA Device
- Recall date
- Jul 29, 2026
- Status
- Ongoing
- Company
- Nova Biomedical Corporation
1. What product was recalled?
StatStrip Glucose Hospital Meter System
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Quantity: 10,941 units
Code or lot text: Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- LOT
- Model No: 66739. UDI-DI: 0038548063685. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- RECALL-NUMBER
- Z-3129-2026
StatStrip Glucose and B- Ketone meter
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Quantity: 2,044 units
Code or lot text: Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- LOT
- Model No: 66429. UDI-DI: :00385480664295. Software Versions: All versions 0.00.13.10 through 1.5.14.25.
- RECALL-NUMBER
- Z-3132-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
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10. Where is the official source?
Open the official FDA Device source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.