Official recall record
i-STAT hs-TnI Cartridge
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-21
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
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 2026-10-31.
Record last checked against the registry on 2026-10-31.
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