General Medicine

Certain Detect COVID-19 Tests Recalled Due to Risk of False Negative Results

Avatar photoBrian Park, PharmD
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Detect, Inc. is voluntarily recalling specific lots of the Detect COVID-19 Test™ due to an increased risk of false negative results.

Detect, Inc. is voluntarily recalling 3 lots of the Detect COVID-19 Test™ due to an increased risk of false negative results.

The Detect COVID-19 Test is a molecular, over-the-counter test used to identify SARS-CoV-2 in self-collected nasal swabs. The affected lots (HB264, HY263, and HY264) were distributed to customers from July 26, 2022 to August 26, 2022; all have a use by date of January 1, 2023.

To date, the Company has not received any reports of false negative results related to the affected lots; the recall was issued out of an abundance of caution. According to the Company, the reliability of positive test results is not affected.

Customers can obtain a refund for a recalled test by contacting Detect customer support at (855) 322-3692 or via email at [email protected].

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This article originally appeared on MPR

References:

Voluntary recall of three detect COVID-19 test lots. News release. Detect. Accessed December 13, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-three-detect-covid-19-test-lots.