Nova Biomedical recalls StatStrip Glucose Ketone Hospital Meter System (model 63683) due to software bug causing incorrect glucose/ketone test results to be sent to healthcare systems via WiFi when reviewing results during transmission.
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 63683) because a software bug can cause incorrect blood glucose and ketone test results to be transmitted to healthcare systems. This could lead to improper patient care decisions if healthcare providers rely on these erroneous results.
The software bug causes the meter to send incorrect glucose and ketone test results to healthcare institutions' data systems when a user navigates to the Review Results screen while the meter is still transmitting a test result. This error occurs only during specific WiFi network interactions at healthcare sites using the meter's data management system.
Healthcare facilities using the StatStrip Glucose Ketone Hospital Meter System (model 63683) with software versions v0.0.13.10 to v0.0.13.44. Patients receiving prescription blood glucose ketone testing through this system are most at risk.
Check if your meter has the model number 63683 and software versions from v0.0.13.10 to v0.0.13.44. This system is used for prescription blood glucose ketone testing in healthcare settings.
Verify your meter's software version by checking the device settings or documentation; versions v0.0.13.10 to v0.0.13.44 are affected.
No, this recall applies only to healthcare facilities using the StatStrip Glucose Ketone Hospital Meter System for prescription blood glucose ketone testing.
Check if your meter has model number 63683 and software versions v0.0.13.10 to v0.0.13.44, as these versions have the software bug causing incorrect results.
The recall does not specify a remedy, so healthcare facilities should contact Nova Biomedical directly for guidance on addressing the software issue.
We’ve drafted a message you can send Nova Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0682-2025 — Nova Biomedical Nova Biomedical Hello, I own a Nova Biomedical that is covered by recall Z-0682-2025 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.
