Beckman Coulter Inc. — SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 17, 2025
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.
What's affected?
- Product
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Brand
- Beckman Coulter Inc.
- Lot code
- M404166
Additional details
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2,932 units.
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