Breast Health Test and Mammary Aspiration Specimen Cytology Test: Recall - Instructions For Use, Promotional Claims and FDA Clearance Concerns
[UPDATED 11/12/2013] The FDA Class 1 Recall Notice is now available.
The MASCT System Kits and ForeCYTE Breast Health Tests 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.
Affected customers are asked 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.
[Originally Posted 10/04/2013]
AUDIENCE: Health Professional, Oncology
ISSUE: Atossa Genetics Inc. initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address FDA concerns about the current instructions for use (IFU), certain promotional claims used to market these devices, and the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. To date, Atossa is unaware of any adverse incidents or injuries associated with the use of the ForeCYTE Breast Health test and the MASCT device or the processing method currently identified in the IFU.
BACKGROUND: The MASCT device has been cleared by the FDA for use as a sample collection device, with the provision that the fluid collected using this device can be used to determine and/or differentiate between normal, pre-cancerous, and cancerous cells. 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. This voluntary recall includes the MASCT System Kit and Patient Sample Kit. The vast majority of these products (approximately ninety percent) are in inventory with Atossa’s distributors and the remaining quantities are at customer sites across the United States. See firm press release for a list of products affected by this recall.
RECOMMENDATION: Distributors and customers should contact Atossa at 800-351-3902 to obtain instructions on how to return these products. Customers with questions may contact the company via telephone at 1-888-219-4629 at any time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/04/2013 - Firm Press Release]
[11/12/2013 - Recall Notice - FDA]