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Health Canada Medical devices

Solana® Bordetella Complete Assay

Issued May 22, 2025
Issue
QuidelOrtho received complaints regarding false positive results from customers testing with the Solana® Bordetella complete assay. The false positive results are associated with the Bordetella parapertussis (bpp) results (only) of the assay and only for the specific lot numbers listed above. The Bordetella pertussis (bp) results are not affected. Recall start date: May 7, 2025
Hazard description
Performance
Product
Product name
Solana® Bordetella Complete Assay
Reference
ID
RA-77488