Breast Health Device Recalled
FDA issues warning letter (October 4)
Atossa Genetics Inc. has initiated a voluntary recall to remove from the market a medical device used to collect breast fluid for cancer detection (the ForeCYTE Breast Health Test) along with a specimen test that uses it (the Mammary Aspiration Specimen Cytology Test [MASCT]) 7 months after the FDA said the device needed additional clearance. The recall includes the MASCT System Kit and the Patient Sample Kit. Distributors and customers should stop using these 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 FDA in a warning letter received by the company in February 2013. The FDA raised concerns about 1) the current instructions for use (IFU); 2) certain promotional claims used to market these devices; and 3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen-collection process identified in the current IFU.
The MASCT device has been cleared by the FDA for use as a sample collection device, with the provision that the fluid collected using this device can be used to determine and/or differentiate between normal, precancerous, and cancerous cells. The MASCT device has not been cleared by the FDA for the screening or diagnosis of breast cancer. In addition, the ForeCYTE Breast Health Test has not been cleared or approved by the FDA for any indication.
The ForeCYTE Breast Health Test and the MASCT device are not a replacement for screening mammograms, diagnostic imaging tests, or biopsies.
Source: Atossa Genetics; October 4, 2013.