Medical Device Voluntary Recall - News Release ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT) FOR IMMEDIATE RELEASE

Medical Device Voluntary Recall - News

ForeCYTE Breast Health Test; Mammary

Aspiration Specimen Cytology Test (MASCT)

FOR IMMEDIATE RELEASE: October 4, 2013

1616 EastLake Ave East, Suite 510

On October 4, 2013 Atossa Genetics

Inc. (NASDAQ: ATOS) 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 vast

majority of these products (approximately ninety percent) 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 (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. Atossa will remove existing product from the market until FDA's concerns

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, pre-cancerous, 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. Patients should follow the recommendations and instructions of their physician with respect to breast cancer screening

To date, Atossa is unaware of any adverse incidents or injuries

associated with the use of the ForeCYTE Breast Health test and the MASCT device or the processing method currently identified in

the IFU. Additionally, Atossa is unaware of any risk to health or injury for clinicians or the patient population that have used

these devices. However, these devices may produce false positive or false negative results. Although not cleared or intended for

this use, if these devices are used as a substitute for recommended screening or diagnosis of breast cancer, FDA is concerned that

patients may choose to forgo recommended mammograms and necessary biopsies.

Atossa is working with the FDA on this matter and this voluntary

recall. Atossa is notifying its distributors and customers by certified mail and is arranging for the return of all recalled product(s).

Products affected by this recall are listed in the table below (table 1):

Distributors and customers should contact Atossa at XXX to obtain

instructions on how to return these products. Customers with questions may contact the company via telephone at 1-888-219-4629

Any problems experienced with the use of this product may be

reported to the FDA:

at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

Online (form available to fax or mail), or call FDA 1-800-FDA-1088

Atossa Genetics Inc.:

President and Chief Executive Officer

Chief Financial Officer and General Counsel