Cue Health, maker of the fancy at-home tests and test reader that Google was buying for its employees during the height of the pandemic, received a warning letter dated May 9 from the FDA telling them to cease sale of their at-home COVID-19 tests because and FDA inspection uncovered the fact that they had monkeyed with their reader firmware and their test formulation in a way that would reduce the accuracy of their tests. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cue-health-inc-675673-05092024

The letter says:

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.

Cue Health’s response was to go out of business and lay off all employees effective last Friday.