Z-1249-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2025
- Initiation Date
- February 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 498 US; 1576 OUS
Product Description
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.
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 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
Code Information
Catalog A16364 UDI-DI 15099590201838 Lot 439363