# FDA recall Z-1387-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-02-06.

## Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

## Reason for recall

Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, TX, WA.

## Key facts

- **Recall number:** Z-1387-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-06
- **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-1387-2025

## Citation

> AI Analytics. FDA recall Z-1387-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1387-2025. Source: US FDA. Licensed CC0.

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