Official recall record
Access hsTnI
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-12-04
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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