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.
This recall is currently active, issued February 28, 2025. It was issued by Beckman Coulter, Inc..
- Company
- Beckman Coulter, Inc.
- Recall Initiated
- February 3, 2025
- Posted
- February 28, 2025
- Recall Number
- Z-1249-2025
- Quantity
- 498 US; 1576 OUS
- Firm Location
- Chaska, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, Hungary, India, Italy, Japan, Korea, Republic of, Netherlands, Philippines, Russian Federation, Saudi Arabia, Slovakia, Spain, United Kingdom of Great Britain and Northern Ireland
Lot / Code Info
Catalog A16364 UDI-DI 15099590201838 Lot 439363
Root Cause
Unknown/Undetermined by firm
Action Taken
Firm began notifying customers February 6, 2025. Customers were instructed to discontinue using and discard all remaining reagent packs of the Access EPO reagent lot identified. Customers are advised to share this recall with their medical director and perform a retrospective review of patient test results generated with this lot and assess the need for retesting.