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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 559
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 manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Similar recalls
- HighMedical device assay may report falsely elevated lithium levels
FDA (Devices) · 2022-10-26
- ModerateAtellica CH Diluent Contaminated with Sodium Hypochlorite
FDA (Devices) · 2025-07-02
- HighSiemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results
FDA (Devices) · 2024-04-24
- HighSiemens Atellica IM 1600 Analyzer Software Recall for Discrepant Results
FDA (Devices) · 2021-01-20
- HighLithium diagnostic assay may display falsely elevated results on Atellica CH analyzer
FDA (Devices) · 2022-10-26
- HighSiemens Atellica Solution IM1600 Analyzer Recall for Sample Detection Issues
FDA (Devices) · 2020-07-01