Voluntary Recall of
Three Detect Covid-19 Test Lots

In December 2022, Detect, Inc. voluntarily recalled specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. This Class II recall affected a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021.

There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect conducted a thorough investigation to identify this issue and made the decision to conduct a voluntary recall for these lots. Since issuing this recall out of an abundance of caution, Detect has received reports of two false negative results related to the affected lots. The reliability of positive test results is not affected.

Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date. All the affected tests have now expired and can not be used.

Detect has notified all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests. Test users who attempt to use recalled tests are also notified in the Detect App™ that the test has been recalled and may not be used.

Detect, Inc. has been issuing refunds* for the affected tests (as verified by Detect) upon customers’ acknowledgment of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.

*Detect Hubs, unrecalled tests, and shipping charges are not eligible for a refund.

Please contact our customer support team for questions and further assistance.

Phone: (855) 322 3692

Email: support@detect.com

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