FDA accuses firm of distributing an unapproved Covid-19 test – Boston, Massachusetts

Boston, Massachusetts 2021-06-10 16:55:56 –

TThe Food and Drug Administration announced a recall of the coronavirus rapid antigen test on Thursday, accusing companies of testing to distribute them without regulatory approval and using counterfeit data to boost their performance.

Authorities have announced a “Class 1 recall” (the most serious type of test use that can cause serious injury or death) and fired a warning letter to the Innova Medical Group in Pasadena, California. Not only is there a problem with company data, but there is also a problem with making unapproved rapid testing available to US consumers.

“Our test revealed that the SARS-CoV-2 antigen rapid qualitative test was distributed in the United States without marketing approval, approval, or FDA approval,” the agency wrote. I will.


It’s unclear how many test kits were distributed to whom, but Innova’s unapproved distribution and usage was widespread enough to get the attention of regulators. In August 2020, the company applied for an Emergency Use Authorization (EUA) for rapid antigen testing, as did hundreds of other Covid-19 testing manufacturers with market approval from the FDA. However, although approved for use in the United Kingdom, the test was not approved for use in the United States.

In that letter, the FDA also pointed out serious concerns about the data that Innova uses both to obtain regulatory approval and to facilitate its testing. The agency said it found in the two test kit configurations that Innova contained counterfeit data that extended the effectiveness of the test.


“Clinical performance estimates reported on the 25T and 7T configuration device labels do not accurately reflect the performance estimates observed during clinical studies of the device and can be erroneous or misleading. “The FDA writes.

In addition, authorities have accused the test maker of submitting data to the FDA in an application for emergency use of the test, which appears to have been simply copied from another test maker.

“The data reliability and accuracy issues described here are not well established for the performance of the SARS-CoV-2 antigen rapid qualitative test and are distributed by Innova without FDA approval, approval, or approval. The product is a serious risk to public health, “the authorities wrote.

Innova, whose executives did not respond to a request for comment, is conducting a rapid antigen test in China. The test is widely used in the United Kingdom and is the subject of some controversy there. The piece of paper test kit is intended for use as part of a regular test program, and some experts advertise it as an essential way to control infection. However, the accuracy of Innova’s tests has been questioned, and critics have commented that significantly lower test accuracy than other commercial tests for Covid-19 infection makes it less reliable for use in high-volume testing programs. It states that there is.

The FDA recall applies to the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, 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).

According to the recall, the “performance characteristics of the test are not well established”, which risks both false-negative and false-positive results, which can delay proper diagnosis and treatment.

“The labels distributed in a particular configuration of the test contain performance claims that do not accurately reflect the performance estimates observed during the clinical study of the test,” recall said.

FDA accuses firm of distributing an unapproved Covid-19 test Source link FDA accuses firm of distributing an unapproved Covid-19 test

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