medical Class II Updated 2021-11-10

Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Interface Module to ADVIA Centaur XP/XPT. A

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: UDI 00630414596754
View official government recall

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