Health product recall

DELFIA/AutoDELFIA P1GF Kit (2019-08-07)

Starting date:
August 7, 2019
Posting date:
August 16, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70743



Last updated: 2019-08-16

Affected Products

DELFIA/AutoDELFIA P1GF Kit

Reason

Manufacturer has become aware that the measured PlGF analyte concentrations in patient samples may be decreased on average 50% due to a change in one of the raw materials.

Affected products

DELFIA/AutoDELFIA P1GF Kit

Lot or serial number

673216

Model or catalog number

B055-201

Companies
Manufacturer

Wallac Oy

Mustionkatu 6, P.O. Box 10

Turku

20750

FINLAND