Detect, a health technology company, is voluntarily recalling some lots of its at-home COVID-19 tests, the company said in an statement Monday on the US Food and Drug Administration’s website. There’s an “increased chance” that the tests could give a false negative result, the company said.
The recall affects Detect’s over-the-counter molecular tests that shipped from July 26 through Aug. 26, 2022. Three lot numbers are being recalled: HB264, HY263 and HY264 which includes about 11,000 tests total. All have “use by” dates of Jan. 1, 2023.
Most at-home tests are antigen tests that give you results in about 15 minutes. This Detect at-home tests are molecular and require about an hour to get results. The company describes its tests as “PCR quality,” or the equivalent accuracy of tests offered by medical professionals that are sent to labs for results.
Detect said it hasn’t received any reports of false negatives so far and is issuing the recall “out of an abundance of caution.” The company is investigating the reason for the higher chance of a false negatives.
Positive test results are still considered reliable, Detect said, but anyone with an unused test should throw it out. The company will issue refunds for verified purchases.
False negatives — a negative result from a COVID-19 test when the person testing actually does have the virus — are common with at-home rapid antigen tests. However, false negatives are less common with molecular testslike the Detect tests being recalled.
Because home tests are less reliable (specifically, a negative result can’t always be trusted, especially if someone has COVID-19 symptoms) the FDA has recommended repeatedtesting after a negative resultregardless of symptoms.
According to Detect’s website and apparently unrelated to the recall, Detect no longer sells its COVID-19 tests. The company cites declining demand for COVID-19 tests and its focus on other health home testing.
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The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.