September 2021 : Notification of Initiation of FSCA (MY-FSN-RDS-Molecular Lab-2021-011) - cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion.
Notification of Initiation of FSCA (MY-FSN-RDS-Molecular Lab-2021-011) - cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion.
Affected Medical Device : cobas EGFR Mutation test v2(Identifier: 07248563190)
MDA Reference Number : MDA/FCA/2021-P131
MDA Registration Number :
IVDC71619177218
IVDC7183621-56115
Decription : false Mutation Detected results for the exon20 insertion (Ex20Ins) mutation when using the cobas®EGFR Mutation Test v2.
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]
