December 2021 : Notification of Initiation of FSCA (MY-FSN-CPS-2020-091) - version 8 Elecsys CA 19-9 : Non-reproducible elevated results with certain reagent lots on cobas e 801.
Notification of Initiation of FSCA (MY-FSN-CPS-2020-091) - version 8 Elecsys CA 19-9 : Non-reproducible elevated results with certain reagent lots on cobas e 801.
Affected Medical Device : Elecsys CA 19-9
MDA Reference Number : MDA/FCA/2021-P184
MDA Registration Number : IVDC53289203518
Description :
The increased frequency of non-reproducible elevated results has been detected for reagent lots 416245, 483123 and 504743 which were released with restrictions in the former versions of MY-FSN-CPS-2020-001.
Local Establishment Contact Detail :
Tiffany Soon
Regulatory Affairs Executive
Roche Diagnostics (M) Sdn. Bhd.
B-20-1, Level 20, The Ascent, Paradigm,No. 1, Jalan SS7/26A, Kelana Jaya,47301 Petaling Jaya, Selangor,Malaysia
+60 3 7967 2388
+60 3 7967 2250
Email : [email protected]
