Siemens Atellica Sample Handler Software Recall for Diagnostic Errors
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler software versions 1.13 and lower due to five behavioral issues that may cause incorrect sample processing or result reporting.
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 source text describes software behavioral issues that may lead to incorrect diagnostic results or sample handling errors, but does not report any hospitalizations, serious injuries, or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling five (5) units of the Atellica Sample Handler Additional (SMN 11069004) software, version 1.13 and lower. The Atellica Solution is a multi-component system used for in vitro diagnostic testing of clinical specimens. The recall is due to the identification of five specific behavioral issues in the software.
The identified issues include: 1) The Reagent Lock may not function as intended when multiple lots of specific reagent kits are loaded simultaneously; 2) Sample barcodes may be incorrectly read; 3) The Atellica IM 1300 and 1600 Analyzers may not run CEA dilutions at 50x and 100x, potentially posting a 'Sample Integrity Error'; 4) The Atellica CH 930 Analyzer may continue to display default reporting units even after they have been changed; and 5) The Atellica CH 930 Analyzer may not display results for samples if certain assays are configured to auto-dilute results outside the assay measuring interval.
The affected software was distributed nationwide and in foreign countries including Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Republic Korea, Singapore, Spain, Sweden, Switzerland, U.A.E., and the United Kingdom. Users of the Atellica Solution system should contact Siemens Healthcare Diagnostics for further instructions on software updates or remediation.
The recalled product
- Product
- Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 5
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)
- Software (SW) version 1.13 and lower
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →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
- HighSiemens Atellica Analyzer Software Recall for Multiple System Issues
FDA (Devices) · 2019-02-06
- ModerateSiemens Recalls Atellica Sample Handler Prime Due to Software Issues
FDA (Devices) · 2019-02-06
- HighSiemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues
FDA (Devices) · 2019-02-06
- HighSiemens Atellica Solution and Sample Handler Prime Recalled for Reporting Errors
FDA (Devices) · 2018-05-09
- ModerateSiemens Atellica CH 930 Analyzer Recall for Software Defect
FDA (Devices) · 2020-05-06
- HighSiemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results
FDA (Devices) · 2020-07-08