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Health Canada Medical devices

Access hsTnI

Issued December 4, 2024
Issue
In remote circumstances, if a sample containing high cardiac troponin (CTNI) >55,000 pg/ml is tested using an access assay other than Access hsTnI, CTNI carryover may occur if the next test performed, using the same probe on that instrument, is Access hsTnI on a different sample. Recall start date: November 18, 2024
Hazard description
Performance
Product
Product name
Access hsTnI
Reference
ID
RA-76641