Product Wiki · Recalls · Health Canada — Medical Devices

Access hsTnI — recall 76641

Health Canada — Medical Devices · Canada · 2024-12-04 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76641
Date of alert
2024-12-04
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Chemistry
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/access-hstni-0

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