Occupied by dipshits
FDA pulled it in 2021 both the home testing and PCR test for false positives.
https://www.fda.gov/medical-devices/medical-device-recalls/ellume-recalls-covid-19-home-test-potential-false-positive-sars-cov-2-test-results
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these tests may cause serious adverse health consequences or death.
Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021.
Recalled Product
Product Names: Ellume COVID-19 Home Test
Product Codes and Lot Numbers: See Medical Device Recall Database Entries or the Ellume Recall Website below in the Additional Resources section
Manufacturing Dates: February 24, 2021 to August 11, 2021
Distribution Dates: April 13, 2021 to August 26, 2021
Devices Recalled in the United States: 2,212,335
Date Initiated by Firm: October 1, 2021
Device Use
The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older. The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms. This at-home test uses swab samples taken
https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html
07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing
After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.
Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.
https://www.fiercebiotech.com/medtech/fda-adds-class-i-recall-label-to-abbott-alinity-covid-tests-high-risk-false-positives
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