The Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test were recalled for marketing without approval or clearance. The ForeCYTE Breast Health Test is a diagnostic test that has not been cleared or approved by the FDA for any indication or 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 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 manufacturer. 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 the FDA clear certain changes made to the process of collecting fluid from the nipples; and (4) the requirement that the 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.
See the FDA Announcement
See also Medical Law Perspectives, October 2012 Report: Mistakes in Diagnosing Cancer: Liability Concerns for Misdiagnosis, Failure to Diagnose, and Delayed Diagnosis