Jun 2021 : Initiation of FSCA (MY-FSN-RDS-CoreLab-2021-006) - cobas® 6500: possible sample mismatch software 2.3.0 – 2.3.6.
Initiation of FSCA (MY-FSN-RDS-CoreLab-2021-006) - cobas® 6500: possible sample mismatch software 2.3.0 – 2.3.6.
Affected Medical Device : cobas6500 urine analyzer series
MDA Reference Number : MDA/FCA/2021-P084
MDA Registration Number : IVDB53037209818
Decription : a possible sample mismatch on the cobas 6500 urine analyzer series with software version 2.3.6
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]
