Nova Biomedical recalls StatStrip Glucose Ketone Hospital Meter System (model 63910) due to software bug causing inaccurate glucose/ketone results when transmitting test results via WiFi. Affected units may send wrong data to healthcare systems.
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
Nova Biomedical is recalling its StatStrip Glucose Ketone Hospital Meter System (model 63910) because a software bug can cause inaccurate blood glucose and ketone test results to be sent to healthcare systems via WiFi. This could lead to incorrect medical decisions if the results are used for patient care.
The software bug causes the meter to send incorrect glucose and ketone test results to healthcare institutions' data systems when the user checks the Review Results screen during a test transmission. This could lead to wrong medical decisions if the inaccurate results are used for patient care.
Healthcare facilities using the StatStrip Glucose Ketone Hospital Meter System (model 63910) with software versions v0.0.13.10 to v0.0.13.44. Patients receiving blood glucose tests through this system are at risk of inaccurate results.
Check for the model number 63910 on the device. The software versions affected are v0.0.13.10 to v0.0.13.44. This meter is used for prescription blood glucose ketone testing in healthcare settings.
Look for the software version on the device; affected versions are v0.0.13.10 to v0.0.13.44.
The meter is safe for use but may send inaccurate results if the software bug is present. Users should check the software version to ensure it's not affected.
Healthcare facilities should check the software version and contact Nova Biomedical if they have affected units to get the correct version.
The recall does not mention a risk of serious injury; the hazard is inaccurate results that could affect medical decisions.
We’ve drafted a message you can send Nova Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0683-2025 — Nova Biomedical Nova Biomedical Hello, I own a Nova Biomedical that is covered by recall Z-0683-2025 from Nova Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
