# FDA recall Z-2575-2025

> **Beckman Coulter Inc.** · Class II · device recall initiated 2025-08-13.

## Product

UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer  REF:B23858

## Reason for recall

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV and the countries of Algeria, Argentina, Australia, Bahrain, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Egypt, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Korea Republic of, Kuwait, Kyrgyzstan, Libya, Lithuania, Mexico, Nepal, Netherlands, New Zealand, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay, Vietnam.

## Key facts

- **Recall number:** Z-2575-2025
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-13
- **Report date:** 2025-09-24

- **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-2575-2025

## Citation

> AI Analytics. FDA recall Z-2575-2025. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2575-2025. Source: US FDA. Licensed CC0.

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