FDA-Device2025-11-12Class IIPROCESSING DEFECT
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
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.
Who it affects
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
2,932 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2026Don't want to check this manually?
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