Covid-19: High False-Positive Rate Leads To Recall Of 2 Million-Plus Home Tests For Virus

The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms.

The test uses swab samples taken from further up inside the nose but not as deep inside the nose to reach the back of the throat where a health care professional collects a sample, the FDA said, noting the Ellume test uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.

Customers can find product lot numbers on the sticker on the side of the Ellume COVID-19 Home Test carton. Compare the lot number to the recalled lot numbers listed in the Medical Device Recall Database Entry. Affected tests purchased by consumers but not yet used will be disabled via a software update, the FDA said.

Ellume will also inform customers who used an affected test and received a positive result.

The reliability of negative test results is not affected, said the FDA.

For these tests, a false positive test result shows that a person has the virus when they do not have it and could lead to:

• Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID-19.
• Further spread of the COVID-19 virus when presumed positive people are grouped into cohorts (that is, they are housed together) based on false test results.
• The person receiving unnecessary COVID-19 treatment from a health care provider, such as antiviral treatment, convalescent plasma, or monoclonal antibody treatment, which can result in side effects.
• Disregard for the recommended precautions against COVID-19, including vaccination.
• Isolation, including monitoring household or close contacts for symptoms, limiting contact with family or friends, and missing school or work.

There have been 35 reports of false-positive results sent to the FDA and no deaths reported.

For more information on the recall, check the FDA advisory here.

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