{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Seattle",
      "state": "WA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "66433",
      "recalling_firm": "Atossa Genetics, Inc.",
      "address_1": "1616 Eastlake Ave E Suite 4411",
      "address_2": "N/A",
      "postal_code": "98102-3788",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "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.",
      "recall_number": "Z-0042-2014",
      "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.    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: 9002513; 9002513MD;  9002528; 9002528MD; 9002587;   9002614; and 9002717MD.    THE MASCT SYSTEM KIT CONSISTS OF:    1. MASCT Breast Pump;  2. Instructions for Use (IFU);  3. Heating Pad;  4. Timer;  5. Saccomono's Fixative;  6. Nu Prep Gel;  7. Welcome and Training Materials Coversheet;  8. MASCT System Order Form;  9. ForeCYTE Training Video DVD;  10. MASCT System Instructions with pictures - pink;    THE PATIENT SAMPLE KIT CONSISTS OF:    1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder);  2. Instructions for Use (IFU);  3. Two (2) specimen collection devices;  4. Two (2) breast bags for transporting the specimen collection container;  5. Barcode labels;  6. Saccomono's Fixative;  7. Nu Prep Gel;  8. MASCT System package insert;  9. ForeCYTE Test Requisition Form;  10. Patient Information Sheet;  11. Atossa Patient Information;  12. FED EX Clinical PAK;  13. MASCT System Order Form;  14. FED EX Pouch;  15. FED EX Airbill;    Product 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.",
      "product_quantity": "577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)",
      "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",
      "recall_initiation_date": "20130919",
      "center_classification_date": "20131028",
      "termination_date": "20140819",
      "report_date": "20131106",
      "code_info": "ALL LOTS"
    }
  ]
}