medical Class I Updated 2025-01-01

Nova Biomedical Corporation recalls StatStrip Glucose Ketone Hospital Meter System. Model/Catalo

Recalled Product

StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
View official government recall

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