Ogos 2021 : Initial Reporting FA-000604 Field Safety Notification on Access hsTnI Reagent - Potential intra-assay carryover with the Access hsTnI (High Sensitivity Troponin I) assay
Initial Reporting FA-000604 Field Safety Notification on Access hsTnI Reagent - Potential intra-assay carryover with the Access hsTnI (High Sensitivity Troponin I) assay
Affected Medical Device : Access hsTnI Reagent
MDA Reference Number : MDA/FCA/2021-P133
MDA Registration Number : IVDC65070375519
Decription : Potential intra-assay carryover with the Access hsTnI (High Sensitivity Troponin I) assay as previously described in IPN-000328
Local Establishment Contact Detail :
Teoh Siang Yee
Senior Quality Specialist
No. 18, Jalan Tandang 51/205A, Seksyen 51 46050 Petaling Jaya Selangor Darul Ehsan MALAYSIA
+65 85335653
Email : [email protected]
