Atellica CH Urinary/Cerebrospinal Fluid Protein — Class II medical device recall Z-3063-2024
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-09-18, distributed nationwide. The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and A
| Recall number | Z-3063-2024 |
|---|---|
| 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 | 2024-07-29 |
| Classified | 2024-09-06 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BH, BR, CA, CH, CL, CN, CZ, DE, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IN, IT, JO, KE, KR, KW, LV, MX, MY, NL, NO, NZ, OM, PE, PH, PK, PL, PT, PY, RO, SA, SE, SG, SK, TH, TN, TR, TW, UY, ZA |
| UPC / GTIN / UDI-DI | 00630414279206 |
| Lot numbers | 130414 |
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Reason for recall
The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
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-3063-2024. 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.