Siemens Aptio Interface Module may misassociate laboratory test results
Siemens Healthcare's Aptio Automation Interface Module firmware may incorrectly associate test results with the wrong sample IDs, potentially affecting clinical decision-making.
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: This is an FDA Class II medical device recall without reported hospitalizations or injuries. However, the defect affects critical laboratory functionality with direct potential to impact patient care through incorrect clinical decisions. Per the severity rubric, risk-of-harm medical devices without reported injury are classified as High (3).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Aptio Automation Interface Module (firmware versions CENa_3-1-0-1 and lower) used with ADVIA Centaur XP/XPT laboratory analyzers. The company has identified a potential defect in the automation firmware that may lead to incorrect associations between test results and sample IDs.
This defect could impact clinical interpretations and clinical decisions made by healthcare providers, as incorrect sample identification in laboratory results can lead to wrong diagnoses or treatment decisions.
Approximately 1,142 units are affected by this recall and have been distributed worldwide. Healthcare facilities operating the affected devices should contact Siemens Healthcare Diagnostics, Inc. for updated firmware and guidance on verifying the integrity of recent test results.
The recalled product
- Product
- Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,142
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 00630414596754
Distribution
Distribution scope not specified by the agency.
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