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Detect issues COVID-19 test recall over false negatives

According to Detect, "there is an increased chance" that the recalled COVID-19 tests may give false negative results.

WASHINGTON — Around 11,000 at-home COVID-19 tests are being recalled because of the possibility of false negative results.

Detect, Inc. announced it is voluntarily recalling three specific lots of its over-the-counter nasal swab test. 

In total, the recall affects 11,102 tests shipped from Detect to customers from July 26, 2022 through Aug. 26, 2022. All of the recalled tests have a use by date of Jan. 1, 2023.

According to the company, "there is an increased chance" that these tests may give false negative results. The company stressed that the "reliability of positive test results is not affected." 

Consumers should verify the lot number, which can be found on the side of each test box, to double check whether their tests are affected. The Detect lots included in the COVID test recall are HB264, HY263 and HY264. 

Credit: Detect, Inc. via FDA
Detect, Inc. is voluntarily recalling specific lots of its Detect Covid-19 Test due to false negative results.

"Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution," the company said in the recall posted on the FDA's website.

Anyone in possession of unused tests from the affected lots should throw them out. Those who attempt to use recalled tests will be notified in the Detect App that the test has been recalled and may not be used.

Customers with additional questions can call Detect at 855-322-3692. 

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