—#216139

Product

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

FDA product code: MRR — System, Test, Low Density, Lipoprotein
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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.

Timeline

Recall initiated: 2025-09-17
Posted by FDA: 2025-11-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216139. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.