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Health Canada Medical devices

Xpert® BCR-ABL Ultra

Issued November 19, 2025
Issue
Using Xpert® BCR-ABL Ultra test kits with specimens that have markedly elevated white blood cell count (>30,000 cells/μl) may in rare circumstances cause inaccurate results.
Hazard description
Performance
Product
Product name
Xpert® BCR-ABL Ultra
Reference
ID
RA-81240