Access Erythropoietin — Class II medical device recall Z-1249-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-03-12, distributed in AL, AR, AZ, CA, CT, FL, ID, IL…. Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate
| Recall number | Z-1249-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-02-03 |
| Classified | 2025-02-28 |
| Reported by FDA | 2025-03-12 |
| Distributed | AL, AR, AZ, CA, CT, FL, ID, IL, IN, KS, MA, MI, NC, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WV |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CN, CZ, DE, DK, ES, FR, GB, HU, IE, IN, IT, JP, KR, NL, PH, SA, SK |
| UPC / GTIN / UDI-DI | 15099590201838 |
| Lot numbers | 439363 |
| Model numbers | A16364 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1249-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.