CanadaWhat's being recalled
Companies: Abbott Point Of Care Inc., 400 College Road E., Princeton, New Jersey, United States, 08540.
How to identify it
Affected products: i-STAT hs-TnI Cartridge; Lot or serial number: B26XXX; Model or catalogue number: 09P81-25
Affected products: i-STAT hs-TnI Cartridge; Lot or serial number: C26XXX; Model or catalogue number: 09P81-25
Affected products: i-STAT hs-TnI Cartridge; Lot or serial number: A24XXX; Model or catalogue number: 09P81-25
Affected products: i-STAT hs-TnI Cartridge; Lot or serial number: B25XXX; Model or catalogue number: 09P81-25
Affected products: i-STAT hs-TnI Cartridge; Lot or serial number: A25XXX; Model or catalogue number: 09P81-25
Affected products: i-STAT hs-TnI Cartridge; Lot or serial number: D26XXX; Model or catalogue number: 09P81-25
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States