StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
Reported: January 1, 2025 Initiated: November 20, 2024 #Z-0683-2025
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.
Details
- Recalling Firm
- Nova Biomedical Corporation
- Units Affected
- 1,615 units
- Distribution
- Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing. Recalled by Nova Biomedical Corporation. Units affected: 1,615 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Critical. Recall number: Z-0683-2025.
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