أجهزة طبية
i-STAT hs-TnI Cartridge
Summary
| Type | Health product recall |
|---|---|
| Product | i-STAT hs-TnI Cartridge |
| Issue | Medical devices - Performance |
| What to do | Contact the manufacturer if you require additional information. |
| Audience | Healthcare |
| Brand(s) | Abbott Point Of Care Inc. |
| Last updated | 2026-10-21 |
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
i-STAT hs-TnI Cartridge |
B26XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
C26XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
A24XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
B25XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
A25XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
D26XXX |
09P81-25 |
Issue
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.
Details
| Original published date | 2026-10-21 |
|---|---|
| Alert / recall type | Health product recall |
| Category | Health products - Medical devices - Chemistry |
| Companies | Abbott Point Of Care Inc. 400 College Road E., Princeton, New Jersey, United States, 08540 |
| Published by | Health Canada |
| Audience | Healthcare |
| Recall class | Type II |
| Recall date | 2026-10-15 |
| Identification number | RA-82840 |
Source: Government of Canada, Recalls and safety alerts – https://recalls-rappels.canada.ca/en/alert-recall/stat-hs-tni-cartridge