Siemens Atellica CI Analyzer may produce falsely elevated electrolyte test results
Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall concerns a diagnostic medical device with potential for patient harm through false test results; however, no illnesses or injuries have been reported to date. Risk-of-harm medical devices without reported injury are scored as High per the severity rubric.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 559 units of the Atellica CI Analyzer (Catalog Number 10947347, Software version 1.28.51) due to a software defect affecting the IMT Diluent volume display. The affected units have been distributed worldwide.
The analyzer may not correctly display the remaining IMT Diluent volume percentage, potentially showing that diluent remains when the container is actually empty. When this occurs, test results for sodium (Na), potassium (K), and chloride (Cl) may be falsely elevated. Quality control materials demonstrate the same behavior.
The issue affects clinical laboratories using the analyzer for electrolyte testing. Affected units are identified by UDI-DI Number 630414229560 and Catalog Number 10947347 running Software version 1.28.51. No illnesses or injuries related to this defect have been reported.
The recalled product
- Product
- Atellica CI Analyzer. Catalog Numbers: 10947347.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- false-electrolyte-results
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI Number: 630414229560
- Catalog Number: 10947347. Software version 1.28.51
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03