# FDA recall Z-0429-2026

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-10-01.

## Product

Beckman Coulter UniCel DxI 800, Part Numbers:  973100, A71456; Photometric Chemistry Analyzer

## Reason for recall

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a  Not Ready  or  Paused  state, leading to a delay in obtaining results.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0429-2026
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-01
- **Report date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0429-2026

## Citation

> AI Analytics. FDA recall Z-0429-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0429-2026. Source: US FDA. Licensed CC0.

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