· Published by Health Canada · Official notice
| 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 |
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.