# FDA recall Z-1388-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-02-05.

## Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

## Reason for recall

the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-1388-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-05
- **Report date:** 2025-03-26

- **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-1388-2025

## Citation

> AI Analytics. FDA recall Z-1388-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1388-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*