ClearanceBrief
Recall Z-0042-2014 ยท KNW Instrument, Biopsy

Atossa Genetics, Inc.

Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER

DateOct 28, 2013 (initiated Sep 19, 2013)
StatusTerminated
ReasonAtossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due to 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 cl
Root causeNo Marketing Application
ActionAtossa Genetics Inc. issued a press release to announce a voluntary recall on October 4, 2013. The firm started sending out the URGENT - VOLUNTARY PRODUCT RECALL NOTIFICATION ForeCYTE Breast Health Test; Mammary Aspiration Specimen Cytology Test (MASCT) RESPONSE REQUIRED letter to consignees on October 7, 2013. The letter identified the affected product, problem and actions to be taken. The firm initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. The MASCT device has not been cleared by th
Quantity577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)
DistributionUSA Nationwide Distribution in the states of: AL, CA, FL, GA, IL, IN, KY, MD, ME, MI, MO, NC, ND, NJ, NV, NY, OK, PA, SC, TN, TX, UT, VA, WA, Washington DC, and Puerto Rico.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030443MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
Nastech Pharmaceutical Company, Inc., May 9, 2003