Beckman Coulter recalls Access Erythropoietin (EPO) lot 439363 due to potential false low results in patient tests, which could lead to improper diagnosis. Affected units may need replacement.
Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter Access EPO Recalled: False Low Results Risk Improper Diagnosis.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52981-beckman-coulter-access-epo-recalled-false-low-results-risk-improper. Based on FDA recall #Z-1249-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2025%22&limit=1).
The FDA announced on Feb. 3, 2025, that Beckman Coulter is recalling Access Erythropoietin (EPO), Catalog Number A16364, due to a hazard of falsely decreased results. This may lead to improper diagnosis or repeat testing for patients.
How to tell if you have it
Brand: Beckman Coulter
Product: Access Erythropoietin (EPO)
Catalog Number: A16364
Lot Code: 439363
Units affected: 498 in the US; 1,576 outside the US
The hazard
The affected lot exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with this lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.
Context
GovInfoNow's records show Beckman Coulter 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 (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).
How to tell if you have this one
Check the lot number on the reagent label. The affected lot is 439363. This reagent is used for blood tests and sold by Beckman Coulter.
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 439363 on the Access EPO reagent label.
Where it went and when
Where it was distributed
Distributed in 24 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to AL AR AZ CA CT FL ID IL IN KS MA MI NC NE NJ NY OH OR PA TN TX UT WA WV. International distribution to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Massachusetts, Michigan, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, West Virginia.
Recall timeline
FDA published this recall 37 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-1249-2025 (February 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1249-2025 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.