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May 13, 2024 · The FDA issued a Warning Letter to Cue Health on May 10, 2024, after an inspection revealed the company made changes to these tests and these changes reduced the reliability of the tests to...
May 13, 2024 · Cue Health’s Covid-19 tests could give false results, FDA warns. T he Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19 tests. This follows an FDA ...
May 13, 2024 · The FDA first authorized the Cue Health COVID-19 Test in June 2020, "granted revisions to the authorized labeling on Aug. 20, 2020, and subsequently reissued the emergency use authorization in its ...
May 17, 2024 · References: US Food and Drug Administration. Do not use Cue Health’s COVID-19 tests due to risk of false results: FDA safety communication. Published May 10, 2024.
May 7, 2024 · The VRBPAC is now scheduled to meet on June 5, 2024, to recommend the inclusion of the SARS-CoV-2 coronavirus strain(s) in the 2024-2025 COVID-19 vaccines. FDA Needs More Up-to-Date Information Before Finalizing COVID-19 Vaccines for 2024-2025 — Precision Vaccinations News
May 13, 2024 · CMS# 675673. May 9, 2024. Dear Mr. Sever: The Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Cue Health, Inc. (“Cue Health”, “you ...
May 13, 2024 · May 13, 2024 | staff reporter. Save for later. NEW YORK – The US Food and Drug Administration has issued a warning letter recommending against the use of Cue Health's COVID-19 tests for home, over-the-counter, and patient care use due to an increased risk of false results.
