Field Correction Action Report - DELFIA® Xpress_R2021004 : Potential for decreased analyte measurement with DELFIA® Xpress hAFP, Free hCGß, PAPP-A, and hCG kits

 

 

Affected Medical Device : 

DELFIA Xpress PAPP-A
DELFIA Xpress hAFP Kit

 

MDA Reference Number : MDA/FCA/2021-P182

 

MDA Registration Number : IVDC9464477517

 

Description :

The measured analyte concentrations in occasional patient samples may be decreased with DELFIA® Xpress kit lots identified in the enclosed response form.

 

Local Establishment Contact Detail :

Wong Kuan Chew
Indeok Kim
Sr. Manager Sales
Sr. Manager Regulatory Affairs, KOSJ
Perkin Elmer Sdn Bhd
#02.01 – Level 2, Wisma Academy, Lot 4A, Jalan 19/1, 46300 Petaling Jaya, Selangor, Malaysia
+603-79491118 Ext. 1186

Email : Indeok.Kim@perkinelmer.com

 

 A copy of FSN.