{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122387", "product_res_number": "Z-0042-2014", "event_date_initiated": "2013-09-19", "event_date_posted": "2013-10-28", "recall_status": "Terminated", "event_date_terminated": "2014-08-19", "res_event_number": "66433", "product_code": "KNW", "k_numbers": [ "K030443" ], "product_description": "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.\r\n\r\nThe MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes:\r\n\r\nPRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5.\r\n\r\nPART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD.\r\n\r\nTHE MASCT SYSTEM KIT CONSISTS OF:\r\n\r\n1. MASCT Breast Pump;\r\n2. Instructions for Use (IFU);\r\n3. Heating Pad;\r\n4. Timer;\r\n5. Saccomono's Fixative;\r\n6. Nu Prep Gel;\r\n7. Welcome and Training Materials Coversheet;\r\n8. MASCT System Order Form;\r\n9. ForeCYTE Training Video DVD;\r\n10. MASCT System Instructions with pictures - pink;\r\n\r\nTHE PATIENT SAMPLE KIT CONSISTS OF:\r\n\r\n1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder);\r\n2. Instructions for Use (IFU);\r\n3. Two (2) specimen collection devices;\r\n4. Two (2) breast bags for transporting the specimen collection container;\r\n5. Barcode labels;\r\n6. Saccomono's Fixative;\r\n7. Nu Prep Gel;\r\n8. MASCT System package insert;\r\n9. ForeCYTE Test Requisition Form;\r\n10. Patient Information Sheet;\r\n11. Atossa Patient Information;\r\n12. FED EX Clinical PAK;\r\n13. MASCT System Order Form;\r\n14. FED EX Pouch;\r\n15. FED EX Airbill;\r\n\r\nProduct Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.", "code_info": "ALL LOTS", "firm_fei_number": "3009171441", "recalling_firm": "Atossa Genetics, Inc.", "address_1": "1616 Eastlake Ave E Suite 4411 1616 Eastlake Ave E", "address_2": "Suite 4411", "city": "Seattle", "state": "WA", "postal_code": "98102-3788", "additional_info_contact": "888-219-4629", "reason_for_recall": "Atossa 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_cause_description": "No Marketing Application", "action": "Atossa Genetics Inc. issued a press release to announce a voluntary recall on October 4, 2013.\r\n\r\nThe 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. \r\n\r\nThe 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 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. \r\n\r\nThe 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 and diagnosis.\r\n\r\nDistributors are instructed to notify downstream customers and physicians are instructed to notify patients who have been tested using the MASCT and/or ForeCYTE systems. Consignees should return the Response Form back to Atossa.\r\n\r\nDistributors and customers should call 800-219-4629 to obtain a Returned Materials Authorization (RMA) number to return affected products. \r\n\r\nCustomers with questions about this voluntary recall or Atossa's products, or would like assistance with the recall documentation may contact Atossa at 1-888-219-4629.\r\n\r\nAny problems experienced with the use of this product may be reported to the FDA at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm,\r\nOnline (form available to fax or mail), or call FDA 1-800-FDA-1088.", "product_quantity": "577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)", "distribution_pattern": "USA 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.", "openfda": { "k_number": [ "K201244", "K982401", "K202012", "K974574", "K033700", "K974794", 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