Atellica IM Erythropoietin — Class II medical device recall Z-1280-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-03-20, distributed nationwide. Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health
| Recall number | Z-1280-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2024-01-24 |
| Classified | 2024-03-11 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BH, BR, CH, CN, CO, CZ, DE, DK, EC, EG, ES, FR, GB, GR, HR, IN, IT, JP, KR, LV, MY, NL, NO, PK, PL, PT, RO, SA, SE, SI, SK, TH, TW, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414245775 |
| Lot numbers | 53982039, 55439041 |
Product
Atellica IM Erythropoietin (EPO) Assay (100 Test)
Reason for recall
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
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-1280-2024. 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.