medical Class II Updated 2025-03-12

Beckman Coulter, Inc. recalls Access Erythropoietin (EPO), Catalog Number - A16364 a glyc

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AR, AZ, CA, CT, FL, ID, IL, IN, KS, MA, MI, NC, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WV
Lot/Code Info: Catalog A16364 UDI-DI 15099590201838 Lot 439363
View official government recall

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