The letter doesn&#x27;t seem to be saying the tests don&#x27;t work, or that they&#x27;re vaporware. It is only finding &quot;noncompliance&quot;. Looking at the first item, &quot;Hematology&quot; (<a href="https:&#x2F;&#x2F;www.law.cornell.edu&#x2F;cfr&#x2F;text&#x2F;42&#x2F;493.1215" rel="nofollow">https:&#x2F;&#x2F;www.law.cornell.edu&#x2F;cfr&#x2F;text&#x2F;42&#x2F;493.1215</a>), it could just be that one of the conditions here (<a href="https:&#x2F;&#x2F;www.law.cornell.edu&#x2F;cfr&#x2F;text&#x2F;42&#x2F;493.1269" rel="nofollow">https:&#x2F;&#x2F;www.law.cornell.edu&#x2F;cfr&#x2F;text&#x2F;42&#x2F;493.1269</a>) wasn&#x27;t met. Those look pretty easy to fix!<p>Of course, yes, there could also be all sorts of crazy sketchy voodoo. Ya never know.