Julai 2021 : FSCA Notifications - 062 CN POC 21-022 RAPIDLab 1200 Lactate Sensor : Potential Lactate Signal Carryover on RAPIDLab 1200 Lactate Sensors
FSCA Notifications - 062 CN POC 21-022 RAPIDLab 1200 Lactate Sensor : Potential Lactate Signal Carryover on RAPIDLab 1200 Lactate Sensors
Affected Medical Device : RAPIDLab 1200 Lactate Sensors
MDA Reference Number : MDA/FCA/2021-P112
MDA Registration Number : IVDC27805171918
Decription : A potential issue with the lactate signal (i.e., hysteresis) whichpresents as carryover on some RAPIDLab 1200 lactate sensors.
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
