Nova Biomedical StatStrip Glucose Hospital Meter System Recalled for Software Defect
Nova Biomedical is recalling StatStrip Glucose Hospital Meter Systems due to a software defect that can cause patient glucose results to be assigned to the wrong medical record.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum severity score of 4 (Severe) due to the reasonable probability that use of the product will cause serious adverse health consequences, such as misassigned medical records leading to inappropriate clinical interventions.
Plain-English summary
Nova Biomedical Corporation is recalling 10,941 units of the StatStrip Glucose Hospital Meter System, Model No. 66739. The recall covers software versions 0.00.13.10 through 1.5.14.25. The devices were distributed nationwide in the US and in 22 foreign countries, including Austria, Belgium, Brazil, Canada, and the United Kingdom.
The recall is due to a software synchronization and timing issue in the barcode scanning component. This defect can cause the device to intermittently retain a previously scanned barcode, such as a patient ID or quality control solution ID, when a new barcode is scanned. If an operator accepts the incorrectly displayed patient information, the current patient's glucose result may be assigned to the previous patient's medical record. Consequently, the current patient's record will not receive the result, leaving their glucose status unrecorded. The previous patient may receive inappropriate clinical intervention based on the erroneous result, particularly in critically ill patients, neonates, and infants.
The defect does not affect the analytical accuracy of the glucose measurements themselves. The issue also affects quality control barcode scanning, potentially attributing QC results to incorrect identifiers or causing unrecognized QC test failures. Consumers and healthcare facilities should contact Nova Biomedical Corporation for further instructions on how to address the software defect.
The recalled product
- Product
- StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
- Manufacturer
- Nova Biomedical Corporation
- Category
- Medical Device — Glucose Meter
- Affected units
- 10,941
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Nova Biomedical Corporation
See all →- CriticalNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
- CriticalNova StatStrip Glucose Hospital Meter System Recalled for Software Defect
FDA (Devices) · 2026-09-23
- HighNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
- HighNova Biomedical StatStrip Glucose Meter Recalled for Data Error
FDA (Devices) · 2026-09-23
- SevereBlood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results
FDA (Devices) · 2025-01-01
Same hazard · software defect
See all →- SeverePTW Freiburg Recalls VERIQA RT MonteCarlo 3D Software Due to Bolus Display Error
FDA (Devices) · 2026-09-23
- HighNuclein DASH Rapid PCR Instrument Recalled for Software Issue
FDA (Devices) · 2026-09-23
- HighMedos Velys Robotic-Assist Station Recalled for Software Movement Issue
FDA (Devices) · 2026-09-09
- HighBaxter Novum IQ Syringe Pump Recalled for Software Infusion Issue
FDA (Devices) · 2026-09-09
- HighBaxter Novum IQ Syringe Pump Software Issue Recall
FDA (Devices) · 2026-09-09
Similar recalls
- CriticalNova StatStrip Glucose Hospital Meter System Recalled for Software Defect
FDA (Devices) · 2026-09-23
- HighNova Biomedical Recalls StatStrip Glucose Meters Due to Software Defect
FDA (Devices) · 2026-09-23
- SevereGlucose Hospital Meter Software Bug Transmits Inaccurate Results
FDA (Devices) · 2025-01-01
- SevereBlood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results
FDA (Devices) · 2025-01-01
- SevereBlood glucose ketone meter software bug causes erroneous result transmission
FDA (Devices) · 2025-01-01
- SevereNova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage
FDA (Devices) · 2014-01-15