Atellica CH Urinary/Cerebrospinal Fluid Protein — Class II medical device recall Z-2542-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2025-09-17, distributed nationwide. Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
| Recall number | Z-2542-2025 |
|---|---|
| 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 | 2025-08-11 |
| Classified | 2025-09-08 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, KW, LV, MX, MY, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 11,811 units |
| UPC / GTIN / UDI-DI | 00630414279206 |
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Reason for recall
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
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-2542-2025. 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.