Nova Biomedical Corporation: StatStrip Glucose Ketone Hospital Meter System.
Recall reason: 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.. Recalled by Nova Biomedical Corporation. Distribution: Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.. Classification (Class I — serious health hazard). Affected lots/dates: Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0
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