Health Canada — Medical Devices · Canada · 2021-08-19 · Type II
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Reported risk: LPN-000328, which was distributed in April 2020, notified customers of possible carryover with in-use, open (punctured) access hsTnI reagent packs, and the impact of carryover on patient samples that are tested from the same reagent pack as a sample with a high cardiac troponin (cTnI) concentration >270,000 pg/mL (ng/l). A subsequent investigation has determined that, under certain conditions, carryover may also impact a different access hsTnI reagent pack. Clinically significant carryover into a different pack can only occur if access hsTnI is the test performed immediately after a sample with a cTnI concentration >270,000 pg/mL (ng/l) and uses the same reagent pipettor. Typically, cTnI concentrations >270,000 pg/mLpg/ml (ng/l) are not routinely observed in patients presenting to the emergency department with chest pain. Although clinically significant carryover is rare, it can affect the results of all subsequent samples that are tested from the affected pack.
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