FDA Device recall Z-0597-2025
Atellica CI Analyzer
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Atellica CI Analyzer by Siemens Healthcare Diagnostics, citing 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 s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0597-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-04 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CI Analyzer. Catalog Numbers: 10947347.
Reason
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.
Identifiers
| code_info | UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Siemens Healthcare Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2025%22
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