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

FDA device recall Z-0441-2026 · posted 2025-11-06 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Inc.

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.

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

MRR

Quantity affected

2,932 units

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 o

Date initiated

2025-09-17

Date posted

2025-11-06

Location

Brea, CA