FDA-Device2021-11-10Class II
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
Siemens Healthcare Diagnostics, Inc.
Hazard
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.
Sold states
Worldwide distribution.
Affected count
1142
Manufactured in
500 Gbc Dr, N/A, Newark, DE, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0193-2022Don't want to check this manually?
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