Recall Z-0682-2025— Nova Biomedical Corporation
Class I · Ongoing
Class I FDA medical device recall by Nova Biomedical Corporation, initiated 2024-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing. 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..
- Recalling firm
- Nova Biomedical Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-11-20
- Firm location
- Waltham, MA, United States
Product description
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.