In a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.
Based in Pasadena, CA, Innova bills itself as the "world's largest provider of rapid antigen tests," and also sells reporting and tracing applications for COVID-19. On its website, the company says it delivered over 220 million COVID-19 test kits to more than 20 countries worldwide.
But the FDA noted that Innova on April 23 recalled its Innova SARS-CoV-2 Antigen Rapid Qualitative Test; the FDA identified the action as a class I recall, the most serious type of recall. The FDA said use of the test could lead to both false-positive and false-negative results.
In its June 10 communication, the FDA advised healthcare providers to stop using Innova's antigen test, and to either destroy or return the tests to the company. Consumers who may have received the test should consult with their physicians.
If the test was administered less than two weeks ago, healthcare providers should consider using a different diagnostic test if they suspect inaccurate results. If testing was conducted more than two weeks ago and there is no reason to suspect infection with SARS-CoV-2, there is no reason to retest.
In conjunction with the letter, the FDA issued a warning letter to Innova Medical that noted that the antigen test is being sold commercially "without marketing approval, clearance, or authorization from the FDA."
In the letter, the FDA claimed that Innova Medical shipped antigen tests to customers in Indiana, New York, Vermont, and Oregon in January and February of 2021 after receiving them from a contract manufacturer in China. The FDA claims the tests were not inspected or verified after being received from China, nor were records maintained showing the tests had been approved for use.
The letter also stated that clinical data that Innova Medical submitted in its request for emergency use authorization for the antigen test "was identical to data previously provided by other manufacturers in their separate [emergency use authorization] EUA requests." This raises concerns that the performance of the test has not been established, the agency noted.
"We request that you take immediate action to cease the sale and distribution of such unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19," the FDA letter to Innova Medical stated.
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