Lower riskMedical device recall · FDA · Published November 20, 2024
Nova Biomedical StatStrip Glucose Meter: Erroneous Test Results Risk
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.
Take action
Contact the company
📍Recalling firmNova Biomedical Corporation200 Prospect St · Waltham, MA 02453-3407
“Nova Biomedical StatStrip Glucose Meter: Erroneous Test Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53458-nova-biomedical-statstrip-glucose-meter-erroneous-test-results-risk. Based on FDA recall #Z-0681-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0681-2025%22&limit=1).
Nova Biomedical Corporation recalled the StatStrip Glucose Hospital Meter System (Model 63685) on Nov. 20, 2024, according to the FDA. A software bug may transmit erroneous glucose results to hospital data systems, risking incorrect patient treatment.
How to tell if you have it
Nova Biomedical StatStrip Glucose Hospital Meter System
Model/Catalog Number: 63685
Software Versions: v0.0.13.10 to v0.0.13.44
UDI-DI (01)10385480636858
The hazard
A software bug in the Gen 2 StatStrip Hospital Meter firmware causes erroneous glucose results to transmit to a healthcare institution's data management system if a user navigates to the Review Results screen during transmission. This risk may lead to incorrect treatment based on documented high or low glucose levels.
Context
GovInfoNow's records show Nova Biomedical Corporation has 3 other recalls since June 19, 2017. Other recent recalls of similar products include Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall: Incorrect Low Glucose Results (Nov. 24, 2025) and Medtronic CareLink Clinic Software Error May Cause Incorrect Glucose Readings (Oct. 21, 2025).
How to tell if you have this one
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.
Brand
Nova Biomedical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Recall number
Product, codes & lots
Quantity
Z-0681-2025
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.; Model No 63685. UDI-DI (01)10385480636858. Software Versions: v0.0.13.10 to v0.0.13.44
2,365 units
Z-0682-2025
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing; Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
347 units
Z-0683-2025
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing; Model No 63910. UDI-DI (01)1038548063910. Software Versions: v0.0.13.10 to v0.0.13.44.
1,615 units
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version on the device or packaging; affected versions are v0.0.13.10 to v0.0.13.44.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0681-2025 (November 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0681-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.