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Open, Classified

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

FDA Recall Z-0193-2022 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeCDT
Date Initiated2021-10-06
Product Quantity1142

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc. · 2005-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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