Siemens ADVIA Chemistry XPT Software Recall for Sample Processing Error
Siemens is recalling ADVIA Chemistry XPT software version 1.0.2 because samples may remain in an 'Inprocess' state, preventing test results from transmitting to the Laboratory Information System.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software error that delays result transmission and requires manual intervention, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Chemistry XPT System, specifically software version 1.0.2. The recall involves 16 units distributed in the United States (Arizona, California, and Washington) and internationally (Germany, Italy, Spain, and the United Kingdom). The affected software is identified by specific lot numbers and material numbers listed in the recall documentation.
The recall is due to a software defect that may cause samples to remain in an 'Inprocess' state. When this occurs, test results for those samples will not transmit to the Laboratory Information System (LIS). Manual intervention is required to complete the processing of samples held in this state.
Healthcare facilities using the affected software should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue and ensure proper sample processing.
The recalled product
- Product
- ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. The ADVIA XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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 (17)
- Software Version 1.0.2
- Lot Numbers: CA1275000080008
- CA1275000090009
- CA1275000060006
- CA1275000050005
- CA1275000070007
- CA1275000130013
- CA1275000100010
- CA1275000120012
- CA1275000170017
- CA1275000260026
- CA1275000270027
- CA1275000280028
- CA1275000240024
- CA1275000200020
- CA1275000220022
- CA1275000410041
Distribution
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
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSiemens ADVIA Chemistry XPT Systems Recalled for Multiple Software Issues
FDA (Devices) · 2016-02-10
- HighADVIA Chemistry XPT System Software May Report Incorrect Patient Test Results
FDA (Devices) · 2021-07-14
- ModerateSiemens ADVIA Centaur XPT Software Recalled for Potential Result Errors
FDA (Devices) · 2016-07-27
- ModerateSiemens ADVIA Centaur XPT Software Recall for Workflow Issues
FDA (Devices) · 2017-03-29
- HighSiemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors
FDA (Devices) · 2015-11-04
- HighSiemens ADVIA Chemistry XPT Software Recall for Result Overwrite Risk
FDA (Devices) · 2015-01-21