Let's remember, this is the bullying organization,
Post# of 22453
Just like the recent news of doctors resigning from the review panels because they FDA granted authorization to drugs the the review panels voted to deny. They (FDA) are not concerned with health, they are focused on money and political agendas.
The recall of Innova seems to be centered around, "You don't have our approval and authorization to conduct business and make money!"
This is why it is good that they do sp much overseas.