September 2021 : FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.
FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.
Affected Medical Device : Interface Module to the ADVIA®Centaur XP/XPT
MDA Reference Number : MDA/FCA/2021-P138
MDA Registration Number : IVD62653244817A
Decription : The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID. The default configuration of our solution flags any tube with this occurrence with error code 3160 or 0D60 “Sampling Not Successful”, however, an improper management of the sample may bring an incorrect patient result.
Local Establishment Contact Detail :
Wilson Ng
Siemens Healthcare Sdn. Bhd.
Quality & Technology
HC APC ASN MAS QT
Level 16-1 & 16-2, CP Tower
No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya,Selangor Darul Ehsan, Malaysia
Tel: +60 3 79525555
Email : weil-shern.ng@siemens-healthineer
