Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Recall date

September 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0441-2026

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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