# FDA recall Z-1115-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-01-03.

## Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

## Reason for recall

A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany,   Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.

## Key facts

- **Recall number:** Z-1115-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-01-03
- **Report date:** 2025-02-12

- **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-1115-2025

## Citation

> AI Analytics. FDA recall Z-1115-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1115-2025. Source: US FDA. Licensed CC0.

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