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Atossa Genetics Inc Announces Medical Device Voluntary Recall

Friday, 4 Oct 2013 05:00pm EDT 

Atossa Genetics Inc announced that it initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. This voluntary recall includes the MASCT System Kit and Patient Sample Kit. The majority of these products are in inventory with Atossa's distributors and the remaining quantities are at customer sites across the United States. Distributors and customers should stop using affected products and return them to Atossa immediately. Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA raised concerns about the current instructions for use (IFU); certain promotional claims used to market these devices; and the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. Atossa will remove existing product from the market until FDA's concerns are addressed. 

Company Quote

22 Aug 2014