Atellica CH Iron3 — Class II medical device recall Z-1549-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-04-24, distributed nationwide. Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers w
| Recall number | Z-1549-2024 |
|---|---|
| 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 | 2024-03-13 |
| Classified | 2024-04-16 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CO, CW, CZ, DE, DK, EE, ES, FI, FR, GR, HR, HU, IE, IL, IN, IT, LT, LV, MX, NL, NO, NZ, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, TR, TW, ZA |
| Quantity | 8,721 units |
| UPC / GTIN / UDI-DI | 00630414610849 |
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 for recall
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.
Machine access
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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.