Field Safety Notification FA-21066 on COULTER 4C-ES Cell Controls : Issue with flagging on White Blood Cell (WBC) values and differential parameters for COULTER 4C-ES Cell Controls.

 

 

Affected Medical Device : COULTER 4C-ES Cell Controls

 

MDA Reference Number : MDA/FCA/2021-P156

 

MDA Registration Number : IVDB29021262718

 

Description :

Beckman Coulter has confirmed intermittent asterisk (*) flags on WBC and differential parameters for the Abnormal Low control. Control results are recovering within values in the Table of Expected Results included in the product packaging.

 

Local Establishment Contact Detail :

Siang Yee Teoh
Senior Quality Specialist
Beckman Coulter Malaysia Sdn. Bhd
No. 18, Jalan Tandang 51/205A, Seksyen 51 46050 Petaling Jaya, Selangor Darul Ehsan MALAYSIA
+65 85335653

Email : steoh@beckman.com

 A copy of FSN.