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.
Beckman Coulter is recalling a specific batch of Access Erythropoietin (EPO) reagents because they may give false low test results. This could lead to incorrect medical diagnoses or unnecessary repeat testing. The recall affects only a specific lot number.
The affected lot may produce false low results in patient samples, leading to incorrect diagnoses or repeat testing. This happens because the reagent doesn't measure blood levels accurately under certain conditions.
Patients using the Access EPO reagent lot 439363 for blood tests may be affected. Those with kidney conditions or needing regular blood monitoring are at slightly higher risk.
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.
Look for the lot number 439363 on the Access EPO reagent label.
The affected lot may produce false low results in patient samples, which could lead to improper diagnosis or repeat testing.
Check the lot number on the reagent label; the affected lot is 439363.
The recall record does not specify a remedy, so contact Beckman Coulter directly for guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1249-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1249-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
