Cue Health Covid Scanner

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Do Not Use Cue Health’s COVID-19 Tests

(3 days ago) WebIf you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100. The FDA …

https://www.fda.gov/medical-devices/safety-communications/do-not-use-cue-healths-covid-19-tests-due-risk-false-results-fda-safety-communication

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FDA warns about using over-the-counter COVID-19 tests from …

(Just Now) WebThe FDA first authorized the Cue Health COVID-19 Test in June 2020, "granted revisions to the authorized labeling on Aug. 20, 2020, and subsequently …

https://www.msn.com/en-us/health/other/fda-warns-about-using-over-the-counter-covid-19-tests-from-cue-health/ar-BB1mktl5

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Cue Health's Covid-19 tests lead to false results, FDA warns - STAT

(9 days ago) WebT he Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19 tests. This follows an FDA warning letter to the company last …

https://www.statnews.com/2024/05/13/cue-health-covid-19-test-fda-warning-false-positives/

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Cue Health, Inc. - 675673 - 05/09/2024 FDA

(9 days ago) WebFDA authorized the Cue Health COVID-19 Test under EUA200248 on June 10, 2020, granted revisions to the authorized labeling on August 20, 2020, and …

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

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FDA warns of false results from Cue Health COVID tests

(2 days ago) WebTopics. COVID-19. The Food and Drug Administration (FDA) yesterday urged home test users, caregivers, and health providers not to use Cue Health's COVID-19 …

https://www.cidrap.umn.edu/covid-19/fda-warns-false-results-cue-health-covid-tests

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COVID tests from Cue Health may not be reliable, FDA urges …

(9 days ago) WebCue Health received Emergency Use Authorizations (EUAs) from the FDA in 2020 and 2021 to sell two COVID-19 tests, one for home use and one for clinical use, …

https://www.naplesnews.com/story/news/2024/05/14/cue-health-covid-tests-false-negatives-positive/73682273007/

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Cue Health Cue Reader Review: Accurate and …

(1 days ago) WebDetect’s Covid-19 Starter Kit is $55 and comes with a reusable hub and a test. It has a 97.3 percent accuracy, but you’ll have to wait more than an hour for results rather than 15 to 20

https://www.wired.com/review/cue-health-cue-reader/

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Cue COVID-19 Test for Home and Over The Counter (OTC) …

(1 days ago) WebCue Health Inc. March 5, 2021 Cue COVID-19 Test for Home and Over The Counter (OTC) Use Coronavirus Disease 2019 (COVID-19) 2 • live in or have recently traveled to a …

https://www.fda.gov/media/146469/download

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FDA warns users not to use Cue Health’s at-home Covid-19 tests

(9 days ago) WebThe Cue Health Covid-19 test for home and over-the-counter use was authorised by the FDA for point-of-care testing in June 2020, receiving an emergency …

https://finance.yahoo.com/news/fda-warns-users-not-cue-105158696.html

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Throw out COVID-19 tests made by Cue Health, FDA warns - Yahoo

(7 days ago) WebSAN DIEGO ( KSWB/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests that were manufactured by a California-based …

https://www.yahoo.com/news/throw-covid-19-tests-made-214113525.html

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Cue Health Applies with FDA for Emergency Use Authorization of …

(5 days ago) WebThe Cue Flu + COVID-19 Molecular Test Cartridge uses a lower nasal swab sample and runs on the Cue Reader, which communicates test results digitally to the …

https://www.prnewswire.com/news-releases/cue-health-applies-with-fda-for-emergency-use-authorization-of-its-cue-flu--covid-19-molecular-test-301639461.html

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FDA Says Cue Health COVID-19 Tests May Be Unreliable

(9 days ago) WebThe Food and Drug Administration (FDA) has issued a warning letter to Cue Health regarding its COVID-19 tests used in point-of-care settings (Cue COVID-19 Test) …

https://www.infectiousdiseaseadvisor.com/news/fda-says-cue-health-covid-19-tests-may-be-unreliable/

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Throw out COVID-19 tests made by Cue Health, FDA warns - MSN

(4 days ago) WebCue Health, headquartered in San Diego, received emergency use FDA authorization for two COVID-19 tests early in the pandemic to help people detect if they were infected with …

https://www.msn.com/en-us/health/other/throw-out-covid-19-tests-made-by-cue-health-fda-warns/ar-BB1msMjr

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Cue Health’s First-of-its-Kind COVID-19 Home Test Gets FDA

(1 days ago) WebCue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first …

https://www.fdanews.com/articles/212060-cue-healths-first-of-its-kind-covid-19-home-test-gets-fda-authorization

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

(9 days ago) WebFDA chides Cue Health for changing its home COVID test, tells consumers to throw them out. Earlier this month, the company disclosed in an SEC filing the latest in a …

https://www.fiercebiotech.com/medtech/fda-chides-cue-health-changing-its-home-covid-test-tells-consumers-throw-them-out

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FACT SHEET FOR PATIENTS - HealthPartners

(8 days ago) WebCue Health Inc. Updated: March 26, 2021 Cue COVID-19 Test Coronavirus Disease 2019 (COVID-19) 1 You are being given this Fact Sheet because your sample(s) was tested …

https://www.healthpartners.com/content/dam/brand-identity/pdfs/care/patient-fact-sheet-cue-covid-19-test.pdf

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FDA Warns Against Use of Cue Health COVID-19 Tests 360Dx

(9 days ago) WebNEW 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 …

https://www.360dx.com/regulatory-news-fda-approvals/fda-warns-against-use-cue-health-covid-19-tests

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FDA Authorizes Cue Health's COVID-19 Test for At-Home and …

(3 days ago) WebThe Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test) uses a lower nasal swab and delivers results in about 20 minutes to the user's …

https://www.prnewswire.com/news-releases/fda-authorizes-cue-healths-covid-19-test-for-at-home-and-over-the-counter-use-301241725.html

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FDA warns not to use Cue Health COVID-19 test kits

(3 days ago) WebCue Health also won FDA de novo clearance for its at-home and point-of-care molecular COVID-19 test last year. The FDA says these changes reduced the reliability …

https://www.massdevice.com/fda-warns-cue-health-covid-19-tests/

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Throw out COVID-19 tests made by San Diego company, FDA …

(7 days ago) WebSAN DIEGO (FOX 5/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests that were manufactured by a company based …

https://www.yahoo.com/news/throw-covid-19-tests-made-161038826.html

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CUE COVID-19 TEST FAQ - U.S. Food and Drug Administration

(1 days ago) WebCue Health Inc. Cue COVID-19 Test for Home and Over The Counter (OTC) Use March 5, 2021 Coronavirus Disease 2019 (COVID -19) 2 6. Who is considered at high risk for …

https://www.fda.gov/media/146472/download

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The COVID-19 Test The FDA Now Says You Can't Trust - MSN

(1 days ago) WebS an Diego-based medical tech company, Cue Health, bragged about receiving an industry-first De Novo authorization from the U.S. Food and Drug Administration (FDA) for its at …

https://www.msn.com/en-us/health/other/the-covid-19-test-the-fda-now-says-you-can-t-trust/ar-BB1mntbS

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FDA issues warning to Cue Health over COVID-19 test

(6 days ago) WebPublished 14/05/2024, 08:46 am. 0. HLTH. -5.20%. SAN DIEGO - Cue Health Inc. (NASDAQ:HLTH), a healthcare technology company, has received a warning letter …

https://ph.investing.com/news/company-news/fda-issues-warning-to-cue-health-over-covid19-test-93CH-1257561

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FDA issues warning about Cue tests : r/ZeroCovidCommunity

(6 days ago) WebThe ZeroCovidCommunity is a place where people who are passionate about reducing the transmission of SARS-CoV-2 / Covid-19 and protecting those who are at high risk can …

https://www.reddit.com/r/ZeroCovidCommunity/comments/1crad46/fda_issues_warning_about_cue_tests/

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Cue COVID-19 Test for Home and Over the Counter (OTC) …

(2 days ago) WebThe Cue COVID-19 Test Cartridge will heat up inside the Cartridge Reader for one minute. Insert the Cue Sample Wand with the nasal sample when the Cue Health App screen …

https://www.fda.gov/media/146471/download?attachment

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Why Medicaid’s ‘undercount’ problem counts - The Washington Post

(1 days ago) WebThe FDA is urging health-care providers and consumers not to use at-home coronavirus tests manufactured by Cue Health, following a warning letter to the …

https://www.washingtonpost.com/politics/2024/05/14/why-medicaids-undercount-problem-counts/

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COVID-19 Cue™ COVID-19 Test Instructions For Use For …

(1 days ago) WebThe Cue COVID-19 Test Cartridge should not be in the Cartridge Reader without the inserted Sample Wand for more than 10 minutes. Step 5-9: Test Progress The test will …

https://www.fda.gov/media/138826/download

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