← FDA ENFORCEMENT
Z-0441-2026Class II

Beckman Coulter Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Beckman Coulter Inc.
Product type
Device
Status
Ongoing
Report date
2025-11-12
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.
Firm state
CA
Product quantity
2,932 units
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot info

REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →