# FDA recall Z-0441-2026

> **Beckman Coulter Inc.** · Class II · device recall initiated 2025-09-17.

## Product

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

## Reason for recall

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

## Distribution

Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA, HI, IA, ID, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, PR, QC, SC, TX, WA, WV and the country of Canada.

## Key facts

- **Recall number:** Z-0441-2026
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-17
- **Report date:** 2025-11-12

- **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-0441-2026

## Citation

> AI Analytics. FDA recall Z-0441-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0441-2026. Source: US FDA. Licensed CC0.

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