October 2021 : DELFIA® Xpress Free hCGß kit : Potential for decreased analyte measurement withDELFIA® Xpress Free hCGßkits
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 : [email protected]
