Medical Device Recall: StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Nova Biomedical Corporation · November 20, 2024
Reason for Recall
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.
Distribution
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
States Affected
NATIONWIDE
Quantity Affected
347 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0682-2025
Status: ongoing
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