Julai 2021 : Field Safety Notification FA-000609 on Kaluza C Flow Cytometry Software : Software anomalies in Kaluza C that may lead to the generation of erroneous results.
Field Safety Notification FA-000609 on Kaluza C Flow Cytometry Software : Software anomalies in Kaluza C that may lead to the generation of erroneous results.
Affected Medical Device : Kaluza C Flow Cytometry Software
MDA Reference Number : MDA/FCA/2021-P110
MDA Registration Number : IVD64715975319A
Decription : Beckman Coulter has discovered software anomalies in Kaluza C that may lead to the generation of erroneous results.
Local Establishment Contact Detail :
Winnie Hii Lin Lin
REGULATORY SPECIALIST
Office: 603 7772 8256
No. 18, Jalan Tandang 51/205A, Seksyen 51 46050 Petaling Jaya Selangor Darul Ehsan Malaysia
www.beckmancoulter.com
Email : [email protected]
