Siemens ADVIA Chemistry Systems Recalled for Software Calibration Defect
Siemens is recalling ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400 because specific software versions allow the systems to automatically run assay calibrations and quality control.
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, but the source text explicitly states no illnesses or injuries are reported and the hazard is a software defect regarding automatic calibration, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Siemens ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400. These high-throughput instruments are used to perform assays for general and specialty chemistries, specific protein measurement, drugs-of-abuse testing, and therapeutic drug monitoring. The recall involves 3,759 units distributed worldwide and nationwide in the United States.
The recall is due to a software defect in specific versions of the ADVIA Chemistry software. The affected software allows the system to automatically run assay calibrations and quality control (QC). The affected software versions are ADVIA 1200 V2.00 and V2.01, ADVIA 1650 V3.52 and V4.01, ADVIA 1800 V2.01, and ADVIA 2400 V4.01.
Healthcare facilities and laboratories using these systems should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to resolve the software issue. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,759
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
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 Systems Recalled for Potential Result Misinterpretation
FDA (Devices) · 2014-01-29
- HighSiemens ADVIA 1200 Software Recalled for Ration Parameter Flagging Errors
FDA (Devices) · 2013-11-27
- HighSiemens ADVIA Chemistry System Software Recalled for Flagging Errors
FDA (Devices) · 2013-11-27
- HighSiemens ADVIA Chemistry System Software Recalled for Parameter Flagging Errors
FDA (Devices) · 2013-11-27
- ModerateSiemens ADVIA Chemistry Calibrator Recalled for Calibration Errors
FDA (Devices) · 2020-07-01
- HighSiemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift
FDA (Devices) · 2020-02-26