Siemens Recalls Atellica Sample Handler Prime Due to Software Issues
Siemens Healthcare Diagnostics is recalling 410 Atellica Sample Handler Prime units because software version 1.14.2 and lower contain multiple issues.
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, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or deaths, and the hazard is a software defect rather than a physical safety risk like fire or choking.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 410 units of the Atellica Sample Handler Prime. This in vitro diagnostic device is used for the qualitative and quantitative analysis of various body fluids. The recall is limited to units running software version 1.14.2 and lower.
The recall was initiated because multiple issues were identified in the Atellica Solution System software. The affected products were distributed worldwide, including in the United States and numerous international locations such as Australia, Canada, and the United Kingdom.
The source text does not specify the exact nature of the software issues or provide instructions for consumers on how to proceed. Users of the Atellica Sample Handler Prime should verify their software version and contact Siemens Healthcare Diagnostics for further guidance.
The recalled product
- Product
- Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 410
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 in V 1.14.2 and lower.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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