Reported Nov 6, 2013 · Terminated
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity…
Atossa Genetics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atossa Genetics, Inc. · 1616 Eastlake Ave E Suite 4411 · Seattle, WA · 98102-3788
Is this the product you have?
Brand
25 of 25 products
| # | Product as published |
|---|---|
| 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 |
| 11 | Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder) |
| 12 | Instructions for Use (IFU) |
| 13 | Two (2) specimen collection devices |
| 14 | Two (2) breast bags for transporting the specimen collection container |
| 15 | Barcode labels |
| 16 | Saccomono's Fixative |
| 17 | Nu Prep Gel |
| 18 | MASCT System package insert |
| 19 | ForeCYTE Test Requisition Form |
| 20 | Patient Information Sheet |
- Lot codes and dates
- ALL LOTS
- Amount recalled
- 577 MASCT System kits, 101 Lab Kits, and 2557 Patients Kits (5 test per kit)
Where it was sold
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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