Detect, a health technology company, is voluntarily recalling certain lots of its home COVID-19 tests, the company said Monday in a statement posted on the U.S. Food and Drug Administration website. There is “an increased chance” that the tests will give a false negative result, the company said.
The recall involves Detect’s over-the-counter molecular tests that were shipped from July 26 to August 26, 2022. Three lot numbers are being recalled: HB264, HY263 and HY264 which includes approximately 11,000 tests in total. All have “use by” dates of January 1, 2023.
Most home tests are antigen tests that give you results in about 15 minutes. These home Detect tests are molecular and take about an hour to get results. The company describes its tests as “PCR quality,” or the equivalent accuracy of tests offered by healthcare professionals that are sent to labs for results.
Detect said it had not received any false negative reports so far and was issuing the recall “out of an abundance of caution”. The company is investigating the reason for the higher risk of false negatives.
Positive test results are still considered reliable, Detect said, but anyone with an unused test should throw it away. The company will issue refunds for verified purchases.
False negatives — a negative result from a COVID-19 test when the person being tested actually has the virus — is common with rapid home antigen tests. However, false negatives are less common with molecular tests, such as the Detect tests being recalled.
Because home testing is less reliable (in particular, a negative result can’t always be trusted, especially if someone has symptoms of COVID-19), the FDA recommended repeatingwhatever the 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 home health tests.
The information in this article is for educational and informational purposes only and is not intended to constitute medical or health advice. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.