The U.S. Food and Drug Administration (FDA) on Tuesday announced a COVID-19 test manufacturer is issuing a recall due to false test results. The COVID-19 tests were made by Detect Inc. and were sent to customers between July 26 and Aug. 26 of this year, according to the recall notice. It impacts about 11,000 tests, which were given an FDA emergency use authorization, made by the firm.
“There is an increased chance that the tests from the lot numbers listed below may give false negative results,” the announcement said. “Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots.” Detect Inc. said it has not received any reports of false negative results related to the impacted lots and said the recall is being done “out of an abundance of caution,” stressing that the “reliability of positive test results is not affected.”
“Detect is notifying all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests,” the notice said. “The outer packaging is recyclable while all the test components can be discarded as regular trash. Detect Hubs are not affected by the recall and do not need to be discarded.”