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Class I Medical Device Recall: Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test - Marketing Without Approval or Clearance

Tue, 11/12/2013 - 12:00am
U.S. Food & Drug Administration

Recall Class:  Class I

Date Recall Initiated: September 19, 2013

Products:

  • Mammary Aspiration Specimen Cytology Test (MASCT) System Kit
  • ForeCYTE Breast Health Test

To locate product codes and lot numbers of affected products, refer to Atossa’s Press Release.

The affected products were manufactured and distributed from January 09, 2013 to September 13, 2013.

Use:  The MASCT device is a breast pump used to collect discharge from a women’s breast. The collected fluid can be used to determine and/or differentiate between normal, pre-cancerous, and cancerous cells.

The ForeCYTE Breast Health Test is a diagnostic test that has not been cleared or approved by the FDA for any indication or use.

Recalling Firm:
Atossa Genetics
1616 Eastlake Avenue East
Suite 510
Seattle, WA 98102

Reason for Recall: The MASCT System Kits and ForeCYTE Breast Health Tests are being recalled due to concerns raised by the FDA in a warning letter sent to the company in February 2013. The FDA raised concerns about (1) the current instructions for use (IFU) for the MASCT System Kit; (2) certain promotional claims used to market these devices; (3) the requirement that FDA clear certain changes made to the process of collecting fluid from the nipples; and (4) the requirement that FDA approve/clear the ForeCYTE Breast Health Test.

These devices have not been cleared by the FDA for the screening or diagnosis of breast cancer.  If they are used for these purposes as marketed by the firm, women may choose to forgo recommended mammograms and necessary biopsies, and may experience serious adverse health consequences.  These include false positive test results, which indicate the presence breast cancer when none exists, and false negative test results, which indicate the absence of breast cancer when the cancer exists.  False positive results may lead to needless patient anxiety, along with further testing and treatment that are not necessary.  False negative results may lead to delayed diagnosis and/or delayed treatment of breast cancer, with increased risk of death.

Public Contact: For questions about this recall, contact Atossa Genetics at 1-800-219-4629, 24 hours a day, 7 days a week.

FDA District: Seattle District Office

FDA Comments:  
On October 4, 2013, Atossa Genetics issued a press release announcing a voluntary recall of the MASCT System Kits and ForeCYTE Breast Health Tests.  On October 7, 2013, Atossa Genetics sent an “Urgent – Voluntary Product Recall Notification” letter informing affected distributors and customers of the problem and asked them to do the following:

  • Stop using affected products and return them to Atossa Genetics;
  • Return the Response Form back to Atossa Genetics;
  • For Physicians - Notify patients who have been tested using the MASCT and/or ForeCTYE systems of the problem and actions to be taken; and
  • For Patients – Follow the recommendations and instructions of your physician with respect to breast cancer screening and diagnosis.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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