Health product recall

DELFIA / AutoDELFIA PIGF 1-2-3

Brand(s)
Last updated

Summary

Product
DELFIA / AutoDELFIA PIGF 1-2-3
Issue
Medical devices - Performance issue
What to do

Contact the importer REVVITY HEALTH SCIENCES CANADA, INC. at TURKUQMRESPONSE@REVVITY.COM.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

DELFIA / AutoDELFIA PIGF 1-2-3

More than 10 numbers, contact manufacturer.

B055-301

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Wallac Oy

Mustionkatu 6, Turku, Finland, 20750

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75641

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