FDA Announces Recall of COVID-19 Tests Due to False Results

The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

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.”

The lot numbers and use-by dates of the affected batches can be located on the side of the text box.

“Detect, Inc. will issue a refund for the affected tests (as verified by Detect) upon customers’ acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of,” the firm said via the FDA website.

Consumers with questions can contact Detect Inc. at [phone] or send an email to the company at [email protected].

Other Recalls and Alerts

Since the start of the COVID-19 pandemic, a number of test kits have been recalled or flagged by the FDA.

The FDA in March of this year said that some COVID-19 rapid tests shouldn’t be used due to the possibility they'll produce false results. At the time, agency officials told consumers not to use Celltrion DiaTrust COVID-19 Ag Rapid Test, the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test, and the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).

A month before that, in February, the FDA issued a warning about two tests made by Empowered Diagnostics because the tests aren’t approved by the FDA.

“The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test,” the FDA statement said at the time. “These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.”