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Health Canada Medical devices

Panoscreen I, II, and III Reagent Red Blood Cell, 2-4% Suspension

Issued July 4, 2024
Issue
Some vials of Panoscreen, lot 17845, 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 Panoscreen lot 17845 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
Panoscreen I, II, and III Reagent Red Blood Cell, 2-4% Suspension
Reference
ID
RA-75776