DELFIA® Xpress Free hCGß kit : Potential for decreased analyte measurement withDELFIA® Xpress Free hCGßkits

 

 

Affected Medical Device : DELFIA® XpressFree hCGßkit

 

MDA Reference Number : MDA/FCA/2021-P142

 

MDA Registration Number : IVDC42267716

 

Decription :

The measured free hCGß analyte concentrations in occasional patient samples may be decreased with DELFIA® Xpress Free hCGß kit lots identified above. The issue may also cause failed results. Based on investigation the antifoam concentration of the Free hCGß tracer is incorrect. The issue may lead to occasional pipetting failures of the Free hCGß Tracer during the assay procedure.

 

Local Establishment Contact Detail :

Jasmine Chan
Service Quality Manager, KOSJ
#02.01 –Level 2, Wisma Academy, Lot 4A, Jalan 19/1, 46300 Petaling Jaya, Selangor, Malaysia
+603-79491118 Ext. 1186

Email : Jasmine.chan@perkinelmer.com

 A copy of FSN.