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 : steoh@beckman.com

 

 A copy of FSN.