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The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance.

The agency announced a “Class 1 recall” — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States.

“Our inspection revealed that the SARS-CoV-2 Antigen Rapid Qualitative Test has been distributed in the United States without marketing approval, clearance, or authorization from FDA,” the agency wrote.

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It’s unclear how many of the test kits were distributed or to whom, but Innova’s unapproved distribution and usage was widespread enough to catch the attention of regulators. The company had applied in August 2020 for an emergency use authorization (EUA) for its rapid antigen test, like hundreds of other Covid-19 test manufacturers who have earned market approval from the FDA. But the test had not been cleared for use in the U.S., though it is approved for use in the United Kingdom.

In its letter, the FDA also noted significant concerns with the data Innova is using both to try to get regulatory approval and to promote its tests. The agency said it found that on two of its test kits configurations, Innova included falsified data inflating the tests’ effectiveness.

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“The clinical performance estimates reported in the labeling of the 25T Configuration and 7T Configuration devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices,” the FDA wrote.

In addition, the agency charged that the test maker submitted data to the FDA in its EUA application for the tests that appeared to have been simply copied from other test manufacturers.

“The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorization could present a serious risk to the public health,” the agency wrote.

In a statement emailed to STAT on Friday morning, an Innova spokesperson wrote: “Innova has worked diligently and proactively to address the FDA findings,” since the agency’s inspection of the company’s Pasadena office in March and April. “Some of the corrective actions have been completed, while some are still underway. None of the inspectional observations concern the performance of the test.”

The company acknowledged it had distributed products in the U.S. “to our employees, clinical studies and some customers for evaluations purposes” and said those had been “voluntarily recalled.” In response to the FDA’s allegations about falsified data in its EUA application, the statement said: “It’s not clear what FDA is referring to, but we know that our … manufacturer submitted data to FDA without pursuing EUA and Innova later submitted equivalent data for EUA for the same test under the Innova brand.”

Innova produces its rapid antigen tests in China. Its tests are widely used in the U.K., where they have been the subject of some controversy. The paper-strip test kits are intended to be used as part of a regular testing program, which some experts have touted as an essential way to tamp down infections. But the accuracy of Innova’s tests has been called into question, and critics says the tests’ accuracy, which is significantly lower than other commercial tests for Covid-19 infections, makes them less than reliable to use for mass testing programs.

The FDA recall applies to Innova SARS-CoV-2 Antigen Rapid Qualitative Test, also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).

The recall says the tests’ “performance characteristics have not been adequately established,” creating the risk of both false negative and false positive results, which could delay proper diagnosis and treatment.

“Labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests,” the recall noted.

This story has been updated with a statement from Innova Medical Group.

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