Siemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues
Siemens Healthcare Diagnostics is recalling Atellica Sample Handler Prime software versions 1.13 and lower due to five identified behavioral issues affecting diagnostic testing.
What this means for you
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 could lead to incorrect test results or errors, but does not report any hospitalizations, serious injuries, or deaths.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 107 units of the Atellica Sample Handler Prime (SMN 11069001) 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 24 foreign countries, including Australia, Canada, Germany, and the United Kingdom.
The recall was initiated because five behavioral issues were identified in the software. These issues include the Reagent Lock potentially not working 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 CEA dilutions at 50x and 100x. Additionally, the Atellica CH 930 Analyzer may display default reporting units after changes are made or may not display results for samples configured to auto-dilute.
Healthcare facilities and laboratories using the Atellica Solution system with software version 1.13 or lower are affected. Users should contact Siemens Healthcare Diagnostics for instructions on how to resolve these software issues.
The recalled product
- Product
- Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 107
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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