$heff's $tation of $tocks & $olid DD

[rocketeer357]

ATOS
My order to buy filled at 2.48. Reading the PR, I like that the recall was voluntary. Also, the problem seems to be with the wording of the instructions rather than a fundamental problem with the hardware.

Hopefully the FDA meeting led to clarity about how to write the instructions for use and the limitations of the device so that full approval can happen:

Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current instructions for use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. Atossa will remove existing product from the market until FDA's concerns are addressed.