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Gsp® neonatal galt kit

Official notice

22 May 2026

MediumHealth Canada

An official Health Canada notice concerns Gsp® neonatal galt kit. 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. Published 2026-05-22.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82106

Official notice

2026-05-22

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

1076503301, 1076642001, 1076935501, 1076787301

Skus

3303-001U

Other

RA RA-82106

Model Numbers

3303-001U

Recall Numbers

82106

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Affected products

Product 1

Lot or serial number - 1076503301, Model or catalogue number - 3303-001U

Product 2

Lot or serial number - 1076642001, Model or catalogue number - 3303-001U

Product 3

Lot or serial number - 1076935501, Model or catalogue number - 3303-001U

Product 4

Lot or serial number - 1076787301, Model or catalogue number - 3303-001U

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Wallac.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82106

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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