Jun 2021 : Field Safety Notice RC-21-0021 Software version 4.06 on STA R Max® - Potential rinsing anomaly of needles # 2 and # 3

Field Safety Notice RC-21-0021 Software version 4.06 on STA R Max® - Potential rinsing anomaly of needles # 2 and # 3

Affected Medical Device : STA R Max®analyzer

MDA Reference Number : MDA/FCA/2021-P093

MDA Registration Number : IVDA653222316

Decription : Potential rinsing anomaly of needles # 2 and # 3 on software version 4.06

Local Establishment Contact Detail :

Aisyah
Regulatory Affairs Executive
All Eights (Malaysia) Sdn Bhd
45, Jalan TS6/10A,Subang Industrial Park, 47600 Subang Jaya, Malaysia