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Open, Classified

StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing

FDA Recall Z-0683-2025 · Posted 2024-12-20

Recalling FirmNova Biomedical Corporation
Recall StatusOpen, Classified
Product CodeN/A
Date Initiated2024-11-20
Product Quantity1,615 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.

Firm Action

Nova Biomedical notified consignees via letter on 11/20/2024. Consignees were instructed that all current Nova StatStrip customers that have gone Live with their new meters recently received a meter software update (v.0.0.13.45 or above) from Nova Biomedical to eliminate the potential risk described above. All remaining customers that have been shipped StatStrip meters impacted by this field correction, will have their meter software updated by Nova Biomedical or local dealer prior to going "Live" with their new meters.

Root Cause

Software design

Distribution Pattern

Distribution US Nationwide including Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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