Z-0683-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- November 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,615 units
Product Description
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. 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.
Distribution Pattern
Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Code Information
Model No 63910. UDI-DI (01)1038548063910. Software Versions: v0.0.13.10 to v0.0.13.44.