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 : LHII@beckman.com

 

 A copy of FSN.