# FDA recall Z-1529-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-07-12.

## Product

DxI 9000 Access Immunoassay Analyzer, catalog number C11137    in vitro diagnostic  device used for the quantitative, semi-quantitative, or qualitative  determination of various analyte concentrations found in human body  fluids

## Reason for recall

Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.

## Distribution

OUS (Foreign) distribution to countries of:  Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.

## Key facts

- **Recall number:** Z-1529-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-12
- **Report date:** 2025-04-16

- **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-1529-2025

## Citation

> AI Analytics. FDA recall Z-1529-2025. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1529-2025. Source: US FDA. Licensed CC0.

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