Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use Recalled by Nova Biomedical Corporation Due to A software bug within the Gen 2 StatStrip...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nova Biomedical Corporation directly.
Affected Products
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Quantity: 2,365 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nova Biomedical Corporation
Nova Biomedical Corporation has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report