The Food and Drug Administration has issued a recall for more than 2 million Ellume COVID-19 Home Tests after the device caused “higher-than-acceptable false positive 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,” the agency said in a statement.
The FDA issued an Emergency Use Authorization on Dec.15, 2020 and authorized a revision to the EUA on Feb.11, 2021 to allow the use of the Ellume test. While Ellume is recalling certain lots of tests because of false positives, the reliability of negative test results is not affected, the FDA said.
When tests show positive results that someone has the virus when they don’t, it could lead to the following issues, according to the FDA:
- Delayed diagnosis or treatment for the actual cause of the person’s illness, which could be another life-threatening disease that is not COVID.
- Further spread of the 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 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, 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, according to the agency.
The Ellume test is an antigen test that detects proteins of COVID from a nasal sample in people 2 years or older. It is available for use without a prescription for those with or without COVID symptoms. The at-home test uses a swab sample from further up the nose (mid-turbinate) but not as deep inside the nose as a health care professional would collect a sample (nasopharyngeal). The test then uses an analyzer that connects with an app to show users how to perform the test and understand the results, according to the statement.
Ellume is recommending test users and caregivers check if they have an impacted test. To do so, users can find product lot numbers on the sticker on the side of the Ellume test carton and compare them to the lot number on the recalled lot numbers listed in the Medical Device Recall Database Entry.
Affected tests purchased by consumers but that have not yet been used will be disabled in a software update, the FDA said. Ellume will also tell customers who used an affected test and received a positive result.
The FDA is advising the following actions:
- Remove affected products from shelves and stop sales.
- Quarantine the affected products immediately.
- Contact their Ellume sales representatives for more instructions on disposal.
- Complete and send the acknowledgment form that was included with the recall letter to [email protected].
- Share the recall letter with any accounts or additional locations, if the affected products have been further distributed.
- Immediately notify Ellume of any accounts or additional locations that may have received the affected products.
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