Recall Z-0441-2026— Beckman Coulter Inc.

Name: FDA recall Z-0441-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2025-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-17
Firm location: Brea, CA, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.