Nova Biomedical Corporation: Device Recall
Recall #Z-0683-2025 · 11/20/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-0683-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Nova Biomedical Corporation
- Status
- Ongoing
- Date Initiated
- 11/20/2024
- Location
- Waltham, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,615 units
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.
Product Description
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
Distribution Pattern
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Other Recalls by Nova Biomedical Corporation
- Class I: Dangerous 11/20/2024
- Class I: Dangerous 11/20/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.