I want to believe this Blue Sky , emotionally , but it just doesn’t make any sense. Why wouldn’t they just approve Immunopass then , what is the purpose of doing all this for a wink? I’m not following. Who would the FDA be trying to appease by recalling the test shortly before approving it?
So my bottom line is this: I agree with BlueSkys. This "Class I Recall" in which "There have been no reports of adverse health consequences or death from use of these tests", and which took the FDA over a month to make public, isn't nearly as serious as the FDA wants anyone to believe.
I see this as just a "warning" to anyone else that they had better dot their "i"s and cross their "t"s before they face the same, dire, "Class I Recall" proclamation that Empowered just received.
Interesting that the FDA took over 4 weeks (37 days) to publish this most serious type of recall discovery
I guess, if you are going to "sit" on this for 37 days, then it really wasn't so bad after all?
BUT, if you are going to approve a product, and want to take advantage of the "wink-wink" that Blueskys is suggesting in his "conspiracy theory", then you had better do it before issuing a final decision on the EUA. (In other words, I see this "weak" announcement as a sign that final approval is closer than ever before).
I am SO GLAD to see that this most serious type of recall
The FDA has identified this as a Class I recall, the most serious type of recall.
had nothing what-so-ever to do with the features of the product itself.
In actuality, none of the test results are being called into question at this point either.
The only thing found wrong and being reported here is that the packaging was somehow mislabeled into suggesting that the FDA had scrutinized the product and given its thumbs up for its use.
That's all, folks!
Truly nothing more to see here than just that!
Honestly, if I can scrape up some dry powder, comes next week, I will be taking advantage of those who cannot see the forest for the trees.