Company: Nova Biomedical Corporation
Date of Enforcement Report: 12/20/2024
Class I
PRODUCT
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing
Recall Number:
Z-0681-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Nova Biomedical Corporation
VOLUME OF PRODUCT IN COMMERCE:
2,365 units
DISTRIBUTION:
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
