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Siemens Healthcare Diagnostics, Inc. Recall 88865

Description: 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. Recall 88865 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0193-2022
Event ID88865
Event DescriptionAptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
Product TypeDevices
DistributionWorldwide distribution.
Quantity1142
Recall ReasonThe 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.
Device Classification20211110
Device Code InfoUDI 00630414596754
Center Classification Date20211102
Recall Initiation Date20211006
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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