Beckman Coulter Inc. device recall (Cls II)

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 — Reason: 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. — Status: Ongoing