Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol
- Recalling company
- Beckman Coulter Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 17, 2025
- Reported
- Nov 12, 2025
- 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.
- Status
- Ongoing
- Quantity
- 2,932 units
- Lot / codes
- REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
- Company location
- Brea, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0441-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0441-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.