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U.S. Department of Health and Human Services

Class 1 Device Recall ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT)

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  Class 1 Device Recall ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) see related information
Date Initiated by Firm September 19, 2013
Date Posted October 28, 2013
Recall Status1 Terminated 3 on August 19, 2014
Recall Number Z-0042-2014
Recall Event ID 66433
510(K)Number K030443  
Product Classification Instrument, biopsy - Product Code KNW
Product 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.
Code Information ALL LOTS
Recalling Firm/
Manufacturer		 Atossa Genetics, Inc.
1616 Eastlake Ave E Suite 4411
Seattle WA 98102-3788
For Additional Information Contact
888-219-4629
Manufacturer 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
FDA Determined
Cause 2		 No Marketing Application
Action Atossa 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 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 and diagnosis. Distributors 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. Distributors and customers should call 800-219-4629 to obtain a Returned Materials Authorization (RMA) number to return affected products. Customers 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. 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.
Quantity in Commerce 577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = NASTECH PHARMACEUTICAL COMPANY, INC.
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