Public recall detail

GSP® Neonatal GALT kit

2026-05-22

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Health products Health product recall
Quick summary

Quick summary: GSP® Neonatal GALT kit. Reason: Health product recall. Category: Health products. Date: 2026-05-22.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: GSP® Neonatal GALT kit. Reason: Health product recall. Category: Health products. Date: 2026-05-22.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandWallac Oy
ProductGSP® Neonatal GALT kit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82106

Affected products

ProductGSP® Neonatal GALT kit
Lot1076503301
Model3303-001U
Serial number1076503301
DescriptionGSP® Neonatal GALT kit
ProductGSP® Neonatal GALT kit
Lot1076642001
Model3303-001U
Serial number1076642001
DescriptionGSP® Neonatal GALT kit
ProductGSP® Neonatal GALT kit
Lot1076935501
Model3303-001U
Serial number1076935501
DescriptionGSP® Neonatal GALT kit
ProductGSP® Neonatal GALT kit
Lot1076787301
Model3303-001U
Serial number1076787301
DescriptionGSP® Neonatal GALT kit

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesWallac Oy Mustionkatu 6, Turku, Finland, 20750
Recall date2026-05-15
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82106
Background{}
CompaniesWallac Oy Mustionkatu 6, Turku, Finland, 20750
AudiencesHealthcare
Source updated2026-05-22

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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