Siemens Atellica Sample Handler Software Recall for Diagnostic Errors
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Connect 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 explicitly states no illnesses or injuries were reported. The hazards involve software behavioral issues that may lead to incorrect diagnostic results, fitting the criteria for a moderate severity recall where the risk is theoretical or limited to data integrity rather than direct physical harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 35 units of the Atellica Sample Handler Connect (SMN 11069018) 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 covers units distributed nationwide and in 23 foreign countries, including Australia, Canada, Germany, Japan, and the United Kingdom.
The recall was initiated because five specific behavioral issues were identified in the software. These issues include the Reagent Lock potentially failing to work as intended when multiple lots of specific reagent kits are loaded, sample barcodes being incorrectly read, and the Atellica IM 1300 and 1600 Analyzers potentially failing to run Carcinoembryonic Antigen (CEA) dilutions at 50x and 100x. Additionally, the Atellica CH 930 Analyzer may display default reporting units after changes have been made or may fail to display results for samples with certain auto-dilution configurations.
Healthcare facilities and laboratories using the Atellica Solution system should contact Siemens Healthcare Diagnostics for instructions on how to update the software or resolve these issues. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 35
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.
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