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Investigations  /  12.16.2017

Meridian Bioscience, Inc.

Meridian Subsidiary is Under Investigation for Inaccurate Lead Tests

Investors of Meridian (NasdaqGS: VIVO) filed a securities class action complaint against the company’s officers and directors for alleged violations of the Securities Exchange Act of 1934 between March 25, 2016 and July 13, 2017. According to the complaint, on March 24, 2016, Meridian announced its acquisition of Magellan Biosciences, Inc. and its wholly-owned subsidiary Magellan Diagnostics, Inc. (together “Magellan”). Although Meridian touted the accuracy, simplicity, and speed of Magellan’s diagnostic products, their lead test kits actually provided inaccurate results. On May 17, 2017, the U.S. Food and Drug Administration (“FDA”) warned that Magellan’s lead tests may provide falsely low results and said that an inspection of Magellan’s facility revealed that the company put patients at risk by failing to report that its tests could be inaccurate. On October 23, 2017, the FDA announced that it identified numerous violations of federal law, including marketing modified versions of the company’s blood lead testing systems without the FDA’s required clearance and failing to submit medical device reports to the FDA regarding discrepancies in test results. If Magellan fails to promptly correct its misdeeds, the FDA may take additional action, such as seizure, injunction, and civil monetary penalties.

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