| Z-0042-2014 |
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.
Reason: 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
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2013-09-19 |
Terminated
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