(WWJ) -- The Food and Drug Administration issued a recall of 2.2 million at-home COVID-19 tests after receiving 35 reports from people who have had false positive results.
A class I recall -- the most serious type of recall -- was issued by the FDA for certain lots of the Ellume COVID-19 home test.
According to the FDA, the recall is "because they have higher-than-acceptable false positive test results" for SARS-CoV-2 and advised people against using the impacted lots as "use of these tests may cause serious adverse health consequences or death."
The FDA said these occurrences of false positives are particularly concerning to health officials for many reasons:
· a delayed diagnosis and treatment for the actual cause of a person's illness, which could be a life-threatening disease that isn't COVID-19
· further spread of the virus when presumed positive people are under one roof based on false test results
· unnecessary COVID-19 treatment from a health care provider, such as receiving antiviral treatment, convalescent plasma or monoclonal antibody treatment – which can all results in side effects
· disregard for recommended COVID-19 precautions, like vaccination
· missing school or work along with isolating yourself from family or friends and not monitoring household or close contacts for symptoms.
These at-home tests are available to anyone without a prescription. Individuals swab up inside the nose to collect samples and then use the analyzer -- connected to a smartphone app -- to understand not only how to perform the test, but to interpret results, according to the FDA.
The recalled tests were manufactured from Feb. 24, 2021 to Aug. 11, 2021 and were distributed between Apr. 13, 2021 and Aug. 26, 2021.
To see if your Ellume test is one of the recalled lots, locate the product lot numbers on the sticker on the side of the package and then visit the FDA website to find the catalogue and master lot numbers.
Or, you can visit the Ellume website to determine if your test is part of the recall so you can request a new one.
The reliability of a negative test result is not in question.
