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Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Recalled November 12, 2025 · FDA recall Z-0441-2026 · Beckman Coulter
Hazard
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. · FDA Class II
Units
2,932 units
Sold at
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.
Description
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
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →