Falsely High Troponin Risk Prompts Abbott i-STAT hs-TnI Cartridge Recall 2026

Certain lots of the Abbott i-STAT hs-TnI Cartridge may produce falsely elevated cardiac troponin I results, according to a Health Canada recall notice published on October 21, 2026. The issue affects a medical device used in healthcare settings, and the notice is addressed to a healthcare audience rather than to the general public.

Abbott Point Of Care Inc., the manufacturer, identified that lots beginning with A24, A25, B25, B26, C26 and D26 may have a reduced ability to mitigate certain forms of analytical interference. Health Canada lists the recall date as October 15, 2026, and classifies it as Type II under reference number RA-82840.

Products Affected by This Recall

The recall covers a single product, the i-STAT hs-TnI Cartridge, under model or catalogue number 09P81-25. Six lot prefixes are involved, as listed in the Health Canada notice:

• A24XXX
• A25XXX
• B25XXX
• B26XXX
• C26XXX
• D26XXX

The notice does not state how many cartridges are affected, and it does not list a UPC. Facilities should check the lot number printed on their cartridge stock against the prefixes above.

What Triggered the Recall

According to the notice, the affected lots may be less able to counter certain forms of analytical interference. These include macrotroponin interference and heterophile antibody-related interference. Abbott attributes the problem to variability associated with the alkaline phosphatase component used during reagent manufacturing.

In practical terms, this variability may lead to falsely elevated cardiac troponin I results. Troponin I is a cardiac marker, so an inaccurately high reading could affect how a result is interpreted. The notice states that there is no evidence that the issue has caused falsely low results.

Who Should Be Concerned

The recall is aimed at healthcare audiences, including facilities and professionals who use the i-STAT hs-TnI Cartridge. Health Canada published the alert, and the spatial scope of the notice is Canada. The manufacturer is based in Princeton, New Jersey, in the United States.

Patients are not asked to take any action in the notice. Anyone with questions about a cardiac troponin result obtained with this device should raise them with the healthcare provider who ordered the test.

Steps Healthcare Users Should Take

The only action listed in the Health Canada notice is to contact the manufacturer if you require additional information. Based on that guidance and the lot details published, users may wish to:

• Check the lot numbers of all i-STAT hs-TnI Cartridge stock on hand against the six affected prefixes.
• Identify cartridges under catalogue number 09P81-25 that match those lots.
• Contact Abbott Point Of Care Inc. for additional information about the issue and next steps.
• Refer to the Health Canada notice, reference RA-82840, for the official listing.

The notice does not provide a refund process, replacement details or manufacturer contact numbers. Those details should be obtained directly from Abbott.

Regulatory Response

Health Canada published the notice in its recalls and safety alerts database under the category of health products, medical devices and chemistry. The issue is described as a medical device performance problem. The recall is classified as Type II, and the original publication date is October 21, 2026.

Abbott’s description of the problem is the basis for the alert. The notice reports no evidence of falsely low results, but it does state that falsely elevated cardiac troponin I results may occur with the affected lots.

Quick Facts

• Product: i-STAT hs-TnI Cartridge
• Manufacturer: Abbott Point Of Care Inc.
• Catalogue number: 09P81-25
• Recall date: October 15, 2026
• Published: October 21, 2026
• Recall class: Type II
• Reference number: RA-82840

Healthcare users who rely on this cartridge should review the Health Canada notice and contact Abbott directly with any questions about affected lots.