COVID tests recalled over false negative concerns

Detect is recalling three lots of its COVID-19 tests.
Detect is recalling three lots of its COVID-19 tests.(Source: FDA/CNN)
Published: Dec. 13, 2022 at 8:21 AM CST
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(Gray News) - The company Detect is voluntarily recalling more than 11,000 COVID tests because of an increased risk of false negatives.

The test is an over-the-counter nasal swab.

The three lots of tests – HB264, HY263 and HY264 - were shipped to customers from July 26 to Aug. 26 and have a use by date of Jan. 1, 2023.

Detect said it has not received any reports of false negatives, and the recall is being done out of an abundance of caution.

The reliability of positive test results is not affected, Detect said.

Detect is offering a refund for the affected tests.

The company said it is notifying all customers and distributors affected by the recall. Anyone who has any unused tests affected by the recall should throw the tests away.

You can find more information on the Food and Drug Administration website.