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Health Canada Medical devices

Panther Fusion® GBS Assay

Issued December 30, 2024
Issue
Hologic identified that the reagents, or "pearls", in the Panther Fusion cartridges exhibited abnormalities. Fusion cartridges are susceptible to moisture ingress via vapor transmission as a result of incomplete seals of the cartridge foil and of the flow wrap foil pouch. Recall start date: December 16, 2024
Hazard description
Performance
Product
Product name
Panther Fusion® GBS Assay
Reference
ID
RA-76772