FDA Medical devices recall · November 12, 2025

SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent recall

Read the official FDA notice ↗

Product

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

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

REF: 969706. Lot: M404166. Expiration Date: 30Nov2025

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.

States: Alabama Arkansas California Florida Georgia Hawaii Iowa Idaho Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Missouri Mississippi North Carolina Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Texas Washington West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0441-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.