Atellica CI Analyzer — Class II medical device recall Z-0597-2025
Ongoing recall by Siemens Healthcare Diagnostics, Inc., reported 2024-12-11, distributed nationwide. Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI
| Recall number | Z-0597-2025 |
|---|---|
| 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 | 2024-11-04 |
| Classified | 2024-12-04 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, BG, CA, CH, CL, CO, CZ, DE, EC, EG, ES, FR, GB, GR, HK, HR, HU, IL, IN, IQ, IT, JO, JP, KE, KR, KW, LV, MY, NL, OM, PE, PH, PK, PT, PY, QA, RO, RS, SA, SE, SK, TH, TR, VN, ZA |
| Quantity | 559 units |
| UPC / GTIN / UDI-DI | 00630414229560 |
| Model numbers | 10947347 |
Product
Atellica CI Analyzer. Catalog Numbers: 10947347.
Reason for recall
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
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-0597-2025. 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.