Nova Biomedical Corporation: Device Recall
Recall #Z-0682-2025 · 11/20/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-0682-2025
- 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
- 347 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 Hospital Meter System. Model/Catalog Number: 63683. 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.