Covid-19: Recall Issued For Brand Of Over-Counter Tests That Could Give False Negative Results

A new recall has been issued for a brand of COVID-19 tests due to an increased chance that the tests may give false negative results

Detect COVID-19 Test.
Photo Credit: *FDA*

Joe Lombardi

12/13/2022 7:50 a.m.

Detect, Inc. is voluntarily recalling specific lots of the Detect COVID-19 Test, an over-the-counter test used to identify SARS-CoV-2 (the virus that causes COVID-19) in self-collected nasal swabs.

The recall affects 11,102 tests shipped to customers from July 26, 2022, through Aug. 26, 2022, the company said.

The test was granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in October, 2021.

There is an increased chance that the tests from the lot numbers listed below may give false negative results. All three lot numbers have a use-by date of 1/1/2023:

HB264
HY263
HY264

The lot number can be found on the side of each test box along with the use-by date. (Click on the second image above.)

"Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots," the company announced in a statement. "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 reliability of positive test results is not affected."

For more on the recall from the FDA, click here.

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