SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
FDA Recall #Z-0441-2026 — Class II — September 17, 2025
Product Description
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.
Recalling Firm
Beckman Coulter Inc. — Brea, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,932 units
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.
Code Information
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated