SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Company
- Beckman Coulter Inc.
- Recall Initiated
- September 17, 2025
- Posted
- November 6, 2025
- Recall Number
- Z-0441-2026
- Quantity
- 2,932 units
- Firm Location
- Brea, CA
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
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.
Lot / Code Info
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Root Cause
Nonconforming Material/Component
Action Taken
Beckman Coulter notified consignees via letter on about 09/17/2025. Consignees were instructed to discontinue use of SYNCHRON Systems LDLD reagent lot M404166 and contact Customer Technical Support Center for assistance, review the Safety Data Sheet (SDS) and discard according to laboratory s Standard Operating Procedures and/or your local regulations. The SDS is available at www.beckmancoulter.com. Additionally, Beckman Coulter recommends sharing the content of this letter with laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from the SYNCHRON Systems LDLD reagent lot M404166 to determine if retesting is necessary.