Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37748 |
| Brand Name: | i-STAT hs-TnI cartridges |
| Model: | List number 09P81-25 |
| Affected: | All lots beginning with A24, A25, B25, B26, C26, D26 |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Point of Care Canada Ltd |
| Issue: | The manufacturer 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 problem may result in falsely elevated cardiac troponin I results. There is no evidence that the problem has caused falsely low results. Cartridges can continue to be used and will perform as intended in samples containing no interferent. Serious injuries could occur due to the failure mode associated with this problem. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/10/2026 |
