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FDA announces COVID-19 test recall, tests prone to false negatives

Virus Outbreak FDA
Posted at 8:57 AM, Dec 13, 2022

The Food and Drug Administration said on Tuesday that some COVID-19 tests are being recalled as they are prone to false negative results.

The tests were made by Detect Inc. and shipped to customers from July 26-Aug. 26. The FDA said the reliability of positive results is not affected.

The FDA said it has not received any reports of false negative tests, and the recall was conducted out of an abundance of caution.

The units have a use-by date of Jan. 1, 2023, and contain lot Nos. HB264. HY263 and HY264.

“There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots,” the FDA said.

Detect Inc. can be contacted by emailing support@detect.com for a potential refund.

EDITOR'S NOTE: A previous version of this story incorrectly said the tests were recalled due to false positives.