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Health Canada Medical devices

i-STAT hs-TnI Cartridge

Issued October 15, 2026
Issue
Product i-STAT hs-TnI Cartridge Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
Abbott has identified that lots beginning with A24, A25, B25, B26, C26, and D26 may have a reduced ability to mitigate certain forms of analytical interference, including macrotroponin and heterophile antibody-related interference, due to variability associated with the alkaline phosphatase component used during reagent manufacturing. This issue may result in falsely elevated cardiac troponin I results. There is no evidence that the issue has caused falsely low results.
Product
Product name
i-STAT hs-TnI Cartridge
Reference
ID
RA-82840