# FDA recall Z-1913-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-04-23.

## Product

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

## Reason for recall

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d'lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel,  Portugal.

## Key facts

- **Recall number:** Z-1913-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-23
- **Report date:** 2025-06-11

- **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-1913-2025

## Citation

> AI Analytics. FDA recall Z-1913-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1913-2025. Source: US FDA. Licensed CC0.

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