CanadaWallac Oy's GSP® Neonatal GALT kit (model/catalogue 3303-001U) with lot/serial numbers 1076503301, 1076642001, 1076935501 and 1076787301 is affected. The recall was issued because an observed reduced on-board stability of the assay may increase the likelihood of delayed reporting of patient results due to increased run-QC failures; contact the manufacturer for additional information.
What's being recalled
Companies: Wallac Oy, Mustionkatu 6, Turku, Finland, 20750.
How to identify it
Affected products: GSP® Neonatal GALT kit; Lot or serial number: 1076503301; Model or catalogue number: 3303-001U
Affected products: GSP® Neonatal GALT kit; Lot or serial number: 1076642001; Model or catalogue number: 3303-001U
Affected products: GSP® Neonatal GALT kit; Lot or serial number: 1076935501; Model or catalogue number: 3303-001U
Affected products: GSP® Neonatal GALT kit; Lot or serial number: 1076787301; Model or catalogue number: 3303-001U
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
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