NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky announces it has commenced an investigation of Meridian Bioscience, Inc. (NASDAQ:VIVO) concerning possible violations of federal securities laws.
The investigation concerns Meridian’s subsidiary, Magellan Diagnostics Inc. On May 17, 2017, the U.S. Food and Drug Administration issued a field safety notice advising that customers discontinue use of Magellan’s lead testing system with venous blood samples, following a product recall. Then on October 23, 2017, Magellan received a warning letter from the FDA following an inspection. In its press release of the same day, the FDA stated that the warning letter was the result of “several violations of federal law” by Magellan, including “marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results.” To obtain additional information, go to:
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