# FDA recall Z-1221-2026

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-11-10.

## Product

COULTER DxH Diluent, REF 628017  COULTER DxH ECO Diluent REF C67250    For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers.  For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

## Reason for recall

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Canada, Chile, Mexico, Saint Kitts and Nevis, Trinidad and Tobago, and Viet Nam.

## Key facts

- **Recall number:** Z-1221-2026
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-10
- **Report date:** 2026-02-11

- **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-1221-2026

## Citation

> AI Analytics. FDA recall Z-1221-2026. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-1221-2026. Source: US FDA. Licensed CC0.

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