Atellica CH Revised C Reactive Protein — Class II medical device recall Z-1551-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-04-16, distributed nationwide. Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
| Recall number | Z-1551-2025 |
|---|---|
| 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 | 2025-03-11 |
| Classified | 2025-04-10 |
| Reported by FDA | 2025-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, EE, ES, FI, FR, GR, HK, HR, HU, IE, IL, IN, IT, KR, KW, LT, LV, MY, NL, NO, NZ, OM, PK, PL, PT, QA, RO, RS, SE, SG, SI, SK, TW |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 00630414610887 |
Product
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Reason for recall
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1551-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.