Z-0441-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2025
- Initiation Date
- September 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,932 units
Product Description
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Reason for Recall
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.
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.
Code Information
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025