DELFIA / AutoDELFIA PIGF 1-2-3
Brand(s)
Last updated
Summary
Product
DELFIA / AutoDELFIA PIGF 1-2-3
Issue
Medical devices - Performance
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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