United StatesSYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF 969706, Lot M404166, Expiration Date 30Nov2025 (2,932 units distributed worldwide, including U.S. nationwide distribution in multiple states and Canada) is affected. Beckman Coulter identified that lot M404166 may generate false high LDL cholesterol results; the issue was discovered internally and confirmed on August 19, 2025.
What's being recalled
SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Recalling firm: Beckman Coulter Inc., Brea, CA, United States.
How to identify it
REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)