# FDA recall Z-0279-2025

> **Accriva Diagnostics, Inc.** · Class II · device recall initiated 2024-09-27.

## Product

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

## Reason for recall

Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention.

## Distribution

US: AZ

## Key facts

- **Recall number:** Z-0279-2025
- **Recalling firm:** Accriva Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-09-27
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0279-2025

## Citation

> AI Analytics. FDA recall Z-0279-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0279-2025. Source: US FDA. Licensed CC0.

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