Official recall record
GSP® Neonatal GALT kit
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-05-22
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-06-03.
Record last checked against the registry on 2026-06-03.
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