Lower riskMedical device recall · FDA · Published November 10, 2021
Beckman Coulter SYNCHRON Cholesterol Reagent Recall: Errors May Cause Wrong Results
Beckman Coulter recalls SYNCHRON Cholesterol reagent REF 467825 due to potential errors causing inaccurate cholesterol test results. Affected units may show brown particles or calibration failures.
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Take action
Contact the company
📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
“Beckman Coulter SYNCHRON Cholesterol Reagent Recall: Errors May Cause Wrong Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61551-beckman-coulter-synchron-cholesterol-reagent-recall-errors-may-cause-wrong. Based on FDA recall #Z-0399-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2022%22&limit=1).
The FDA announced on 2021-11-10 that Beckman Coulter Inc. is recalling SYNCHRON Systems Cholesterol (CHOL) Reagent because it may fail with calibration errors, potentially leading to erroneous low cholesterol patient results.
How to tell if you have it
Brand: Beckman Coulter
Product: SYNCHRON Systems Cholesterol (CHOL) Reagent
REF: 467825
Lot: M106450
UDI: 15099590575113
The hazard
The cholesterol reagent may fail with Out of Calibration Range Low and/or Back to Back errors, and low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may also be observed. Continued use may lead to failed QC and/or calibrations or erroneous low cholesterol patient results.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since 2017-06-20. Other recent recalls include DxC 500 AU Clinical Chemistry Analyzers (2026-09-02), DxC 500i Modules with Software 1.5 (2026-07-15), and MicroScan LabPro V5.03 Panel Update 11 DVD Kit (2026-06-26). Similar product recalls include LDL Cholesterol Reagent (2025-12-08), Emit 2000 Quinidine Assay (2026-07-13), and AU5800 Chemistry Analyzer (2026-01-30).
How to tell if you have this one
Check for reagent lot number M106450 or unique identifier 15099590575113. The product is labeled SYNCHRON Systems Cholesterol (CHOL) Reagent REF 467825.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Reagent Details
Verify the lot number (M106450) and unique identifier (15099590575113) on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 39 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0399-2022 (November 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0399-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.