Atossa recalls ForeCYTE Breast Health Test, Mammary Aspiration Specimen Test

Atossa Genetics (ATOS) voluntarily recalls the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test to "address concerns raised by the FDA."

The issues the regulator raised include: "Concerns about the current instructions for use, certain promotional claims used to market the devices, and the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid specimen collection process." (PR)

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