Notification of Initiation of FSCA (SB_RDC_2021_03) : Important information about open vials of Accu-Chek®Performa test strips

 

Affected Medical Device : Accu-Chek Performa Tests

 

MDA Reference Number : MDA/FCA/2021-P109

 

MDA Registration Number : IVDC34428161418

 

Decription : Possible that a vial can open in a sealed carton while in transit.

 

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.