# FDA recall Z-0681-2025

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

## Product

StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

## Reason for recall

A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose 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 glucose test result to the DMS.  The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.

## Distribution

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

## Key facts

- **Recall number:** Z-0681-2025
- **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-0681-2025

## Citation

> AI Analytics. FDA recall Z-0681-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0681-2025. Source: US FDA. Licensed CC0.

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