FDA Device recall Z-1549-2024
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using th…
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using th… by Siemens Healthcare Diagnostics, citing potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1549-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-13 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
Reason
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
Identifiers
| code_info | UDI-DI: 00630414610849 All lots |
|---|
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-1549-2024%22
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