A medical device used to collect breast fluid and a test that uses the collected fluid to detect breast cancer has been recalled because they may produce false results. The recall comes seven months after the U.S. Food and Drug Administration (FDA) said the device needed additional clearance because changes were made after the device was approved.
The recall affects Atossa Genetics MASCT (Mammary Aspiration Specimen Cytology Test) collection system and the ForeCYTE Breast Health Test. The MASCT system allows collection of nipple aspirate fluid in physician’s offices for cytological testing. The ForeCYTE Breast Health Test is an early breast cancer warning system that uses the specimen collected by the MASCT system to detect and differentiate among normal, abnormal, and cancerous breast cells.
Atossa chief executive Steven Quay said that the company will submit a new premarket application to the FDA by the end of the month that covers the collection, preparation and processing of breast fluid specimens. The company said that the devices will be pulled from the market until the FDA’s concerns are addressed. According to Atossa, to date, no adverse events or injuries have been reported as a result of using the devices or the test.
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