Nova Biomedical recalls StatStrip Glucose Hospital Meter System (model 63685) due to software bug causing incorrect glucose results in medical records, potentially leading to wrong treatments.
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose 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 glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Nova Biomedical is recalling its StatStrip Glucose Hospital Meter System (model 63685) because a software bug can send wrong glucose test results to healthcare systems. This might cause incorrect patient treatment if the results are used in medical records.
A software bug in the Gen 2 StatStrip Hospital Meter firmware causes the device to send incorrect glucose results to healthcare data systems when users navigate to the Review Results screen during transmission. This could lead to medical records showing high or low glucose levels, potentially causing wrong treatments.
Healthcare providers using the StatStrip Glucose Hospital Meter System (model 63685) for prescription blood glucose testing. Those most at risk are medical staff who rely on the device for patient monitoring.
Check for the model number 63685 on the device or packaging. The software versions affected are from v0.0.13.10 to v0.0.13.44. This product was sold for prescription use in healthcare settings.
Look for the software version on the device or packaging; affected versions are v0.0.13.10 to v0.0.13.44.
The product is safe to use if the software version is not in the affected range (v0.0.13.10 to v0.0.13.44).
The recall does not specify a remedy, so no action is required if the software version is not affected.
Check the software version on the device or packaging; affected versions are v0.0.13.10 to v0.0.13.44.
We’ve drafted a message you can send Nova Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-0681-2025 — Nova Biomedical Nova Biomedical Hello, I own a Nova Biomedical that is covered by recall Z-0681-2025 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.
