Blood glucose ketone meter software bug causes erroneous result transmission
Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.
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: This FDA Class I recall indicates a serious potential health hazard—the agency's highest classification tier. The software bug can cause erroneous glucose and ketone test results to reach hospital data systems, potentially leading to inappropriate patient treatment decisions. No deaths or injuries have been reported.
Plain-English summary
Nova Biomedical Corporation is recalling 1,615 units of the StatStrip Glucose Ketone (mmol/L) Hospital Meter System, Model 63910, a prescription blood glucose ketone meter used in hospital settings. The device has a software bug in firmware versions v0.0.13.10 through v0.0.13.44 that can cause erroneous glucose and/or ketone test results to be transmitted to the healthcare institution's data management system.
The transmission error occurs when a user navigates to the Review Results screen on the meter while a test result is actively being transmitted to the data management system. When this happens, incorrect test values may be sent to the hospital's electronic health record or laboratory information system.
The recalled units have been distributed across the United States, including Puerto Rico, and internationally to Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands. Patients and healthcare providers should contact their hospital's laboratory or medical device support team if they believe they have been affected by this recall.
No illnesses or injuries have been reported at this time. Patients with questions should consult with their healthcare provider or contact Nova Biomedical Corporation.
The recalled product
- Product
- StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
- Manufacturer
- Nova Biomedical Corporation
- Hazard
- software-bug
- erroneous-results
Distribution
Distributed nationwide across the United States.
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