Atellica CH ¿2-Microglobulin — Class II medical device recall Z-0440-2022
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2022-01-05, distributed nationwide. ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias
| Recall number | Z-0440-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2021-12-01 |
| Classified | 2021-12-29 |
| Reported by FDA | 2022-01-05 |
| Terminated | 2023-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CH, CN, CZ, DE, DK, EC, ES, FR, GB, GR, IL, IN, IR, IT, JP, MA, MX, OM, PH, PK, PT, SK, TR, UY, ZA |
| UPC / GTIN / UDI-DI | 00630414595566 |
| Lot numbers | 211446 |
Product
Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
Reason for recall
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
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.