Field Safety Corrective Action (MY-FSN-RDS-CoreLab-2021-009) : cobas u pack (INT) - Updated Urine Interference Claims.

 

Affected Medical Device : cobas u pack (06334601001)

 

MDA Reference Number : MDA/FCA/2021-P097

 

MDA Registration Number : IVDB53037209818

 

Decription : The interference testing of selected drugs and endogenous substances in urine was performed during IVDR readiness activities.

 

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.