Nova Biomedical StatStrip Glucose Meter recalled for patient data mix-up risk
What this means
A software issue in the StatStrip Glucose and B-Ketone meter (Model 66429) can cause the device to display a patient's barcode from a previous test when scanning a new patient's barcode. If an operator doesn't notice the mismatch and accepts the wrong information, one patient's glucose result gets recorded in another patient's medical record, leaving the current patient without a result and potentially leading to incorrect treatment decisions.
- Check with your healthcare facility or lab to confirm if you use the affected StatStrip Glucose meter (Model 66429).
- If your facility uses this model, verify patient information matches the barcode on screen before accepting results.
- Contact Nova Biomedical Corporation or your facility's equipment manager for instructions on remediation or replacement.
- Report any instances where patient results may have been mixed up to your medical director or quality control team.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3132-2026More Nova Biomedical recalls
- FDA-Device2026-09-23Nova Biomedical StatStrip Glucose Hospital Meter recalled for barcode scanning errors that may assign results to wrong patients
- FDA-Device2026-09-23Nova Biomedical StatStrip Glucose Hospital Meter recalled for patient data mismatch risk
- FDA-Device2026-09-23Nova Biomedical StatStrip Glucose Meter recalled for patient data mislabeling risk
- FDA-Device2026-09-23Nova Biomedical StatStrip Glucose Meter recalled for patient data misassignment risk
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