Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity Sy

FDA device recall Z-0042-2014 · posted 2013-10-28 · Terminated

Recall details

Recalling firm

Atossa Genetics, Inc.

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

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

KNW

Quantity affected

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.

Date initiated

2013-09-19

Date posted

2013-10-28

Date terminated

2014-08-19

Location

Seattle, WA

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