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 : tiffany.soon@roche.com

 

 A copy of FSN.