Jun 2021 : POC 21-021 RAPIDPoint 500 System Measurement Cartridges : Potential For Lactate Signal Carryover on RAPIDPoint 500 System Measurement Cartridges.
POC 21-021 RAPIDPoint 500 System Measurement Cartridges : Potential For Lactate Signal Carryover on RAPIDPoint 500 System Measurement Cartridges.
Affected Medical Device : RAPIDPoint 500 System Measurement Cartridges with Lactate
MDA Reference Number : MDA/FCA/2021-P083
MDA Registration Number : IVDC6984796818
Decription : Potential issue with the lactate signal (i.e., hysteresis) which presents as lactate carryover on less than 1% of RAPIDPoint 500 Measurement Cartridges. This is not a fluidic issue and no other parameters are affected.
Local Establishment Contact Detail :
Wilson Ng
Siemens Healthcare Sdn. Bhd.
Quality & Technology
HC APC ASN MAS QT
Level 16-1 & 16-2, CP Tower
No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya,Selangor Darul Ehsan, Malaysia
Tel: +60 3 79525555
Email : weil-shern.ng@siemens-healthineer>
