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Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
 

Original Dr. Hulda Clark
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Published: 4 months ago
 

Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results


https://www.fda.gov/medical-devices/medical-device-recalls/ellume-recalls-covid-19-home-test-potential-false-positive-sars-cov-2-test-results#additional
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.

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.
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
 

 
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