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Health Canada Health products

GSP® Neonatal GALT kit

Issued May 15, 2026
Issue
Product GSP® Neonatal GALT kit Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
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.
Product
Product name
GSP® Neonatal GALT kit
Reference
ID
RA-82106