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Beckman Coulter Inc.: SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706

Medical DevicesSource: FDA (device) · Date: 2025-11-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Beckman Coulter Inc.
Product
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-09-17
Code info
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
Product quantity
2,932 units
Voluntary mandated
Voluntary: Firm initiated
City
Brea
State
CA
Country
United States
Event id
97628
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