FSCA LASW 21-01 Aptio Automation : Interface Module to the ADVIA®Centaur XP/XPT

 

 

Affected Medical Device : Aptio Automation Interface Module to the ADVIA Centaur XP/XPT Instrument

 

MDA Reference Number : MDA/FCA/2021-P143

 

MDA Registration Number : IVDA7212861617

 

Decription : Siemens Healthcare Diagnostics Inc. has confirmed that the 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.

 

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>

 A copy of FSN.