Device 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

Z-0193-2022

October 06, 2021

Class II

Product summary

Firm: Siemens Healthcare Diagnostics, Inc.
Event: Event 88865
Status: Ongoing
Classification: Class II
Quantity: 1142
Official record key: device-enforcement:Z-0193-2022

Official wording

Reason: 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.

Code information: UDI 00630414596754

Distribution pattern: Worldwide distribution.

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

Firmware for the ADVIA Centaur XP/XPT Interface Module may