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Ortho-Clinical Diagnostics recall

This article was originally published in The Gray Sheet

Executive Summary

J&J subsidiary voluntarily recalls four lots of its Vitros immunodiagnostic troponin I reagent pack after receiving complaints of random false-positive results. Malfunction of the cardiac marker used worldwide to aid diagnosis of myocardial infarction is attributed to a component's interaction with patient plasma samples. Replacements for the affected lots - 2510 and 2530 in the U.S. and 1110 and 1130 worldwide - have been supplied to labs. No injuries have been reported, according to the firm...



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