Siemens Atellica CH 930 Analyzer Recall for Software Defect
Siemens is recalling Atellica CH 930 Analyzers with specific software versions due to a defect that may cause incorrect test results.
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, and the hazard involves potential incorrect test results without reported injuries or hospitalizations, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,807 units of the Atellica CH 930 Analyzer, Siemens Material Number 11067000, equipped with software version v1.21.0 SP1 or lower. The recall covers units distributed in the United States and globally.
The recall is issued because editing an assay Test Definition and switching to another assay's Test Definition screen without saving the changes may corrupt the settings of the assay's test definition. This corruption can cause Auto-Rerun or Auto-Dilution results to generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
Healthcare facilities and laboratories using these analyzers should contact Siemens Healthcare Diagnostics for instructions on how to resolve the software issue.
The recalled product
- Product
- Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,807
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 (1)
- UDI: 00630414002163
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 →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSiemens Atellica CH 930 Analyzer Software Recall for Discrepant Results
FDA (Devices) · 2021-01-20
- ModerateSiemens Atellica Analyzer Software Recall for Diagnostic Errors
FDA (Devices) · 2018-10-24
- HighSiemens Atellica CH 930 Analyzer Recalled for Calibration Error
FDA (Devices) · 2019-12-04
- HighClinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results
FDA (Devices) · 2022-01-12
- HighSiemens Atellica CH 930 Analyzer Recalled for Erroneous Hemolysis and Lipemia Indices
FDA (Devices) · 2019-10-23
- ModerateSiemens Atellica CH 930 Analyzer Recalled for Barcode Scanning Error
FDA (Devices) · 2020-02-05