The Recall Desk
SevereFDA (Devices)·Z-0682-2025·Announced 2025-01-01

Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results

Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification establishes a minimum severity score of 4. No reported deaths or serious injuries are documented in the source text, so the score remains at 4 (Severe) rather than escalating to 5 (Critical).

Plain-English summary

Nova Biomedical Corporation is recalling the StatStrip Glucose Ketone Hospital Meter System (Model 63683) due to a software bug in the meter firmware. When a user navigates to the Review Results screen while the meter is transmitting a test result to a healthcare institution's data management system over WiFi, the firmware may send erroneous blood glucose and/or ketone patient test results to that system.

The affected meters were distributed nationwide in the United States and in Puerto Rico, Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands. A total of 347 units are affected by this recall.

Healthcare facilities and users of affected meters should verify that test results displayed on the meter match those in their healthcare institution's data management system. Any discrepancies should be investigated to ensure patient medical records are accurate. For additional information regarding this recall, contact Nova Biomedical Corporation.

The recalled product

Product
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Blood Glucose Ketone Meter
Hazard
Affected units
347

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Nova Biomedical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Nova Biomedical Corporation

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