# FDA recall Z-0683-2025

> **Nova Biomedical Corporation** · Class I · device recall initiated 2024-11-20.

## Product

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

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

## Key facts

- **Recall number:** Z-0683-2025
- **Recalling firm:** Nova Biomedical Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-20
- **Report date:** 2025-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0683-2025

## Citation

> AI Analytics. FDA recall Z-0683-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0683-2025. Source: US FDA. Licensed CC0.

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