warning letter

Cue Health COVID
MedTech

FDA tells users to throw away Cue Health's home COVID tests

Amid layoffs and a CEO turnover, the FDA said that Cue Health's undisclosed changes “reduced the reliability of the tests to detect SARS-CoV-2 virus.”
Conor Hale May 14, 2024 11:19am
SARS-CoV-2

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FDA

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FDA

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FDA

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FDA

FDA slams BD for 510(k) failing, GMP violations in warning letter

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