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Covidien/Mallinckrodt nuclear imaging agent

This article was originally published in The Gray Sheet

Executive Summary

Covidien unit is investigating what caused elevated levels of a nuclear isotope in its generators for one of the most widely used isotopes for nuclear diagnostic imaging studies, technetium-99m. The company declined to comment on specific actions taken to correct the problem, which was identified in January. The Nuclear Regulatory Commission on Feb. 1 issued a confirmatory action letter documenting the agency's understanding of the company's commitments to address reports it received from nuclear pharmacies and hospitals that liquid withdrawn from more than 100 generators had high levels of molybdenum-99, whose radioactive decay produces technetium-99m. The isotope is injected into patients before imaging the kidneys, brain or bone to help diagnose cancer and other diseases

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