—#212434

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.

FDA product code: GGT — Assay, Erythropoietin
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K052223
Affected lot / code info: Catalog A16364 UDI-DI 15099590201838 Lot 439363

Why it was 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.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2025-02-03
Posted by FDA: 2025-02-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212434. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.