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Health Canada Medical devices

Delfia Xpress

Issued January 1, 2022
Issue
We have become aware that the measured analyte concentrations in occasional patient samples may be decreased with the affected Delfia Xpress kit lots. The issue may also cause failed results. Based on investigation the antifoam concentration of the tracers is incorrect at the end of the manufacturing series and therefore only certain tracer vials are affected by the issue. the issue may lead to occasional pipetting failures of the tracer during the assay procedure. Recall start date: 2021-12-17
Hazard description
Performance
Product
Product name
Delfia Xpress
Reference
ID
RA-63781