FDA Device recall Z-1281-2024
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
- FDA Device
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of ADVIA Centaur Erythropoietin (EPO) Assay (100 Test) by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1281-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-24 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Reason
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.
Identifiers
| code_info | Siemens Material Number: 10995096; UDI/DI: 00630414010380; Kit Lots: 53984040, 55443042. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1281-2024%22
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