# FDA recall Z-2268-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-06-25.

## Product

DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A71456

## Reason for recall

Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-2268-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-25
- **Report date:** 2025-08-13

- **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-2268-2025

## Citation

> AI Analytics. FDA recall Z-2268-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2268-2025. Source: US FDA. Licensed CC0.

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