Lower risk Medical device recall · FDA · Published September 17, 2025

Beckman Coulter SYNCHRON LDL Cholesterol Reagent May Give False High Results

Beckman Coulter recalls SYNCHRON Systems Direct LDL Cholesterol reagent lot M404166 due to potential false high cholesterol results. Affected units may need replacement to ensure accurate blood tests.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0441-2026Medical device Beckman Coulter ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling a specific lot of LDL cholesterol reagents because they might give false high results in blood tests. This could lead to incorrect health assessments if used without replacement. Read more at govinfonow.com/recall/51281-beckman-coulter-synchron-ldl-cholesterol-reagent-may-give-false-high.

Source Summary by GovInfoNow · govinfonow.com/recall/51281-beckman-coulter-synchron-ldl-cholesterol-reagent-may-give-false-high · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0441-2026

Cite this page

“Beckman Coulter SYNCHRON LDL Cholesterol Reagent May Give False High Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51281-beckman-coulter-synchron-ldl-cholesterol-reagent-may-give-false-high. Based on FDA recall #Z-0441-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0441-2026%22&limit=1).

The FDA announced on September 17, 2025, that Beckman Coulter Inc. is recalling SYNCHRON Systems Direct LDL Cholesterol (LDL) Reagent because it may generate false high results. The agency issued recall number Z-0441-2026 for the Class II voluntary recall.

How to tell if you have it

Brand: Beckman Coulter
Product: SYNCHRON Systems Direct LDL Cholesterol (LDL) Reagent
REF: 969706
Lot: M404166
Expiration Date: 30Nov2025
Units affected: 2,932

The hazard

Beckman Coulter identified that reagent lot M404166 has an increased probability of generating false high results. The issue was discovered internally and confirmed by the company on August 19, 2025.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11: Incorrect Algorithms May Affect Test Results (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026). Other recent recalls of similar products include Beckman Coulter LDL Cholesterol Reagent May Give False High Results (December 8, 2025), Beckman Coulter Bicarbonate Reagent May Cause False High Results - Recall (October 14, 2025), and Beckman Coulter Emit 2000 Quinidine Assay Recall: Risk of Incorrect Patient Treatment (July 13, 2026).

How to tell if you have this one

Check for the reagent lot number M404166 on the packaging. The product was sold between August 2025 and November 2025 with an expiration date of November 30, 2025.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Reagent Lot Number
Look for the lot number M404166 on the reagent packaging to confirm if it is affected.
Replace Reagent
If the lot number matches M404166, replace it with a verified batch to ensure accurate blood test results.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 30 states.

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA published this recall 56 days after the firm started it.

Sep 17, 2025Firm started the recall
Nov 6, 2025FDA classified it Class II
Nov 12, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51281-beckman-coulter-synchron-ldl-cholesterol-reagent-may-give-false-high">Beckman Coulter SYNCHRON LDL Cholesterol Reagent May Give False High Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0441-2026 (September 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0441-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.