CLN Article

FDA Investigation of Magellan Lead Tests Finds Company Violated Federal Law

Regulatory Roundup: December 2017

The Food and Drug Administration (FDA) has issued a warning letter to Magellan Diagnostics alleging several violations of federal law. In May 2017, FDA advised healthcare institutions that Magellan’s LeadCare tests performed on venous blood might produce falsely low results. To determine the cause of the inaccurate results, the agency then launched an investigation that included an inspection of Magellan’s facility. According to FDA, investigators observed numerous violations during the inspection, including Magellan’s failure to submit medical device reports to FDA after customers raised complaints about discrepancies in test results. In addition, the inspection found that Magellan altered two of its blood lead testing systems after they were already FDA cleared by changing the amount of time that the mixture of blood samples with the reaction substrate must sit before analysis. However, Magellan did not report this significant change to FDA for review and evaluation, as required. If Magellan fails to promptly correct these violations, FDA said that it may take additional action, such as seizure, injunction, and civil money penalties.

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