Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access Erythropoietin (EPO) Recalled by Beckman Coulter, Inc. Due to Affected lot (439363) exhibited a negative dose drop...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.
Affected Products
Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.
Quantity: 498 US; 1576 OUS
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 24 states: AL, AZ, AR, CA, CT, FL, ID, IL, IN, KS, MA, MI, NE, NJ, NY, NC, OH, OR, PA, TN, TX, UT, WA, WV
About Beckman Coulter, Inc.
Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report