Siemens Atellica Solution and Sample Handler Prime Recalled for Reporting Errors
Siemens Healthcare Diagnostics is recalling Atellica Solution and Sample Handler Prime systems because reporting and conversion factors may not apply to all connected analyzers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect could lead to incorrect reporting of clinical test results, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica Solution and Atellica Sample Handler Prime, which are used for in vitro diagnostic testing of clinical specimens. The recall is due to a defect where, when more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
The affected products were distributed in Florida, France, Spain, Sweden, the United Kingdom, and Germany. The specific product code is UDI 00630414002439.
Users of these devices should contact Siemens Healthcare Diagnostics for further instructions on how to address the issue.
The recalled product
- Product
- Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 00630414002439
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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