Atellica¿ CH ¿2-Microglobulin — Class II medical device recall Z-0599-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-12-11, distributed nationwide. Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, u
| Recall number | Z-0599-2025 |
|---|---|
| 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 | 2024-10-21 |
| Classified | 2024-12-04 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HU, IL, IN, IR, IT, JO, JP, KW, MA, MX, OM, PK, PL, PT, PY, RS, SA, SK, TH, TR, UY, VN, ZA |
| Quantity | 11,330 units |
| UPC / GTIN / UDI-DI | 00630414595566 |
Product
Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Reason for recall
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
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.