# FDA recall Z-1664-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-03-27.

## Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

## Reason for recall

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system.  The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1664-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-27
- **Report date:** 2025-04-30

- **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-1664-2025

## Citation

> AI Analytics. FDA recall Z-1664-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1664-2025. Source: US FDA. Licensed CC0.

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