# FDA recall Z-2138-2023

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2023-05-31.

## Product

COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells

## Reason for recall

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Bolivia (Plurinational State of), Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, Indonesia, Kuwait, Mexico, Panama, Peru, Puerto Rico, Taiwan, Trinidad and Tobago, Uruguay, and Viet Nam.

## Key facts

- **Recall number:** Z-2138-2023
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-31
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2138-2023

## Citation

> AI Analytics. FDA recall Z-2138-2023. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-2138-2023. Source: US FDA. Licensed CC0.

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