Recall Monitor
Health Products

i-STAT hs-TnI Cartridge

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: i-STAT hs-TnI Cartridge
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
i-STAT hs-TnI CartridgeB26XXX09P81-25
i-STAT hs-TnI CartridgeC26XXX09P81-25
i-STAT hs-TnI CartridgeA24XXX09P81-25
i-STAT hs-TnI CartridgeB25XXX09P81-25
i-STAT hs-TnI CartridgeA25XXX09P81-25
i-STAT hs-TnI CartridgeD26XXX09P81-25

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.

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