# FDA recall Z-0216-2026

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-09-19.

## Product

DxI 9000 Access Immunoassay Analyzer, Part Number C11137

## Reason for recall

Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0216-2026
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-19
- **Report date:** 2025-10-29

- **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-0216-2026

## Citation

> AI Analytics. FDA recall Z-0216-2026. Retrieved 2026-09-16 from https://api.ai-analytics.org/recall/Z-0216-2026. Source: US FDA. Licensed CC0.

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