Detect, Inc. has recalled specific lots of the Detect Covid-19 Test citing possibility to give false negative results, the U.S. Food and Drug Administration said. The reliability of positive test results is not affected.
The molecular, over-the-counter test is used to identify SARS-CoV-2, the virus that causes Covid-19, in self-collected nasal swabs.
The recall affects a total of 11,102 tests shipped to customers from July 26, 2022 through August 26, 2022. The test was granted Emergency Use Authorization or EUA from the FDA on October 28, 2021.
The affected tests include 7,382 units with lot number HB264, 1,800 units with lot number HB263, and 1,920 units with lot number HB264. The Use By Date of all recalled products is 1/1/2023.
There is an increased chance that the tests from these lot numbers may give false negative results. The issue was identified after a thorough investigation by the company.
However, Detect has not received any reports of false negative results related to the affected lots to date.
The company noted that test users who attempt to use recalled tests will be notified in the Detect App that the test has been recalled and may not be used.
Meanwhile, Detect Hubs are not affected by the recall and do not need to be discarded.
Detect will issue a refund for the affected tests.
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