# FDA recall Z-1326-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-11-13.

## Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

## Reason for recall

The DxI 9000 Access Immunoassay  Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-1326-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-13
- **Report date:** 2025-03-19

- **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-1326-2025

## Citation

> AI Analytics. FDA recall Z-1326-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1326-2025. Source: US FDA. Licensed CC0.

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