—#189788

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

FDA product code: CDT — Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K043546
Affected lot / code info: UDI 00630414596754

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2021-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189788. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.