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Atossa recalls breast health device, shares tumble

Started by riky, October 06, 2013, 09:00:19 AM

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riky

Atossa recalls breast health device, shares tumble

(Reuters) - Atossa Genetics Inc said it would recall a medical device used to collect breast fluid for cancer detection along with a test that uses it, seven months after the U.S. Food and Drug Administration said the device needed additional clearance. Atossa, whose shares fell 46 percent in extended trading, said the MASCT system and the ForeCYTE test may produce false results. The FDA's warning letter on February 21 said the system required additional clearance as changes were made to the collection process after its approval. ...

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