Health product recall

GSP® Neonatal GALT kit

Brand(s)
Last updated

Summary

Product
GSP® Neonatal GALT kit
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

GSP® Neonatal GALT kit

1076503301

3303-001U

GSP® Neonatal GALT kit

1076642001

3303-001U

GSP® Neonatal GALT kit

1076935501

3303-001U

GSP® Neonatal GALT kit

1076787301

3303-001U

Issue

The recall is initiated to inform customers of an observed reduced on-board stability of GSP GALT assay (3303-001U), which may increase the likelihood of delayed reporting of patient results as a result of increased run-QC failures. Please see Medical device recall letter for customer instructions.

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
Recall date
Identification number
RA-82106

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