CoolerPseudonym ,
@CoolerPseudonym@wandering.shop avatar

I dunno if anyone will not have heard, but the fancy Cue Health NAAT molecular test, with the handheld gizmo, has been revealed to be a near-fraud. The FDA found that the company implemented non-approved changes to reagent formulations and device firmware post-EUA that will have significantly reduced the test’s accuracy.

In response to the FDA’s letter, the company elected to go out of business.

Don’t use these tests.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024

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