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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