| TGA Action ID |
RC-2026-RN-00841-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
i-STAT hs-TnI cartridge. An in vitro diagnostic medical device (IVD)
Lot Numbers: All lots beginning with A24, A25, B25, B26, C26 and D26
Expiry Dates: 28 Nov 2026; 25 Feb 2027 and 30 Jun 2027 (lots starting with A24, A25, B25 have expired) |
| ARTG Number |
483645 |
| Unique Device Identifier (UDI) |
(01) 00054749003051 (17) |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Abbott has identified that reagent lots beginning with A24, A25, B25, B26, C26 and D26 may have a reduced ability to mitigate analytical interference, including macrotroponin and heterophile antibody-related interference, due to variability in the alkaline phosphatase component used during reagent manufacture.
This problem may result in falsely elevated cardiac troponin I results. No evidence has been identified that the problem causes falsely low results.
There has been 1 customer complaint, with no injuries or adverse events reported in Australia. Worldwide, Abbott has received 79 reports potentially associated with this problem and 6 reports of unnecessary clinical intervention. |
| Instructions for Customers/Users |
Customers may continue to use affected cartridges in accordance with this notification and existing labelling while transitioning to updated product as it becomes available.
Clinicians should interpret cTnI results alongside the patient's clinical presentation, including signs and symptoms, risk factors, medical history, physical exam findings, and other relevant diagnostic test results. Where cTnI results are inconsistent with the clinical presentation, the possibility of analytical interference should be considered.
If analytical interference is suspected, users should retest the sample using an i-STAT hs-TnI cartridge lot beginning with A26 or use an alternative validated laboratory method.
i-STAT hs-TnI cartridge lots beginning with A26 will be available for distribution starting in mid-October. Please work with your local Abbott representative for transition support as the updated inventory becomes available. |
| Action Commencement Date |
19/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 816 696 - Abbott Point of Care Technical Support |