FDA Enforcement
Class I
Ongoing
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Recall: Z-0682-2025
·
Reported January 1, 2025
Enforcement
- Recall Number
- Z-0682-2025
- Event ID
- 95783
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Nova Biomedical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 1, 2025
- Initiation Date
- November 20, 2024
- Classification Date
- December 20, 2024
- Address
- 200 Prospect St, Waltham, MA, 02453-3407, United States
Description
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.
Code Info
Model No 63683. UDI-DI (01)38548063685. Software versions: v0.0.13.10 to v0.0.13.44.
Distribution
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Quantity
347 units