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Health Canada Medical devices

DELFIA / AutoDELFIA PIGF 1-2-3

Issued June 7, 2024
Issue
We have become aware through customer complaints that the measured PlGF analyte concentrations in part of the patient samples (approximately 15%) may be decreased ≥ 50%. The decreased PlGF concentration results may cause raise in the amount of high risk/false positive pre-eclampsia and Down's syndrome screening results. Recall Start Date: May 29, 2024
Hazard description
Performance
Product
Product name
DELFIA / AutoDELFIA PIGF 1-2-3
Reference
ID
RA-75641