Siemens Atellica Data Manager Software Recalled for Potential Erroneous Patient Results
Siemens Healthcare Diagnostics is recalling Atellica Data Manager software versions 1.0 and 1.1 because unexpected interface driver behavior may cause quality control results to be assigned to incorrect control lot numbers, potentially leading to the reporting of erroneous patient results.
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 3/5 (High).
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 risk-of-harm product (clinical laboratory software) where injury or adverse health consequences have not yet been reported, fitting the criteria for a High severity score (3).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 70 units of Atellica Data Manager software, specifically versions 1.0 (Siemens Material Number 11314237) and 1.1 (Siemens Material Number 11316888). These software modules are used in clinical laboratories to consolidate test orders and results, provide routing information to automation, and manage quality control. The recall covers units distributed worldwide, including the United States and numerous international locations such as Argentina, Australia, Brazil, Germany, India, and the United Kingdom.
The recall was initiated due to unexpected interface driver behavior identified during quality control (QC) processes. This behavior may result in QC results being assigned to an incorrect control lot number. If a QC failure occurs but appears to be passing due to this error, and the issue is not detected during QC review, it could lead to the reporting of erroneous patient results.
The source text does not specify a particular action for consumers or end-users beyond the recall notice itself, nor does it report any specific illnesses, injuries, or deaths associated with this software defect. The hazard is theoretical, based on the potential for erroneous data reporting rather than a direct physical injury mechanism.
The recalled product
- Product
- (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 70
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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