Device product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Z-0441-2026
Product summary
- Event
- Event 97628
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,932 units
- Official record key
device-enforcement:Z-0441-2026
Official wording
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.
Code information: REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.