# FDA recall Z-0541-2026

> **Beckman Coulter Inc.** · Class II · device recall initiated 2025-09-22.

## Product

DxFLEX Flow Cytometer Catalog Number C78500  UDI-DI code: 15099590754013    The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

## Reason for recall

Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.

## Key facts

- **Recall number:** Z-0541-2026
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-22
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0541-2026

## Citation

> AI Analytics. FDA recall Z-0541-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0541-2026. Source: US FDA. Licensed CC0.

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