# FDA recall Z-1546-2024

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-03-05.

## Product

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

## Reason for recall

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

## Distribution

Worldwide -  US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.

## Key facts

- **Recall number:** Z-1546-2024
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-05
- **Report date:** 2024-09-11

- **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-1546-2024

## Citation

> AI Analytics. FDA recall Z-1546-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1546-2024. Source: US FDA. Licensed CC0.

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