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Recall Observatory FDA recall evidence

Device 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.

Z-1249-2025

February 03, 2025

Class II

Product summary

Firm
Beckman Coulter, Inc.
Event
Event 96255
Status
Ongoing
Classification
Class II
Quantity
498 US; 1576 OUS
Official record key
device-enforcement:Z-1249-2025

Official wording

Reason: 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.

Code information: Catalog A16364 UDI-DI 15099590201838 Lot 439363

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.