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Health Canada Medical devices

Panocell-10 (2-4% Suspension) Reagent Red Blood Cells

Issued July 4, 2024
Issue
Some vials of Panocell-10 lot 17905, exhibit an unexpected dark color (hemolysis) and darkening of the red blood cells. It has been confirmed that there is fungal growth in the vials where the hemolysis and darkening of the red blood cells has been observed. This issue is random across kits within Panocell-10, lot 17905 and is not present in all vials within the kit. Fungal contamination may lead to erroneous results. Recall Start Date: June 6, 2024
Hazard description
Performance
Product
Product name
Panocell-10 (2-4% Suspension) Reagent Red Blood Cells
Reference
ID
RA-75777