Julai 2021 : Notification of Initiation of FSCA (SB_RDC_2021_03) : Important information about open vials of Accu-Chek®Performa test strips
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 : [email protected]
