i-STAT hs-TnI Cartridge
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
i-STAT hs-TnI Cartridge |
B26XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
C26XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
A24XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
B25XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
A25XXX |
09P81-25 |
i-STAT hs-TnI Cartridge |
D26XXX |
09P81-25 |
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.
Additional information
Details
Abbott Point Of Care Inc.
400 College Road E., Princeton, New Jersey, United States, 08540
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