Siemens Healthcare Diagnostics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI 00630414596754
Products Sold
UDI 00630414596754
Siemens Healthcare Diagnostics, Inc. is recalling Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmwa due to The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.
Recommended Action
Per FDA guidance
On October 6, 2021, the firm notified affected customers via an "Urgent Medical Device Correction" letter. Customers were informed of the product issue and provided instructions on actions to be taken by laboratories, which prevent the issue from happening. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. A new version of the Firmware for the Aptio Automation Interface Module to the ADVIA Centaur XP/XPT will correct the issue. Your service provider will contact you to schedule the firmware upgrade.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026