The US Food and Drug Administration (FDA) issued a safety warning to the public on Thursday (June 10) to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use.
The test is also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), InnovaSARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).
The FDA said it “has significant concerns that the performance of the test has not been adequately established, presenting a risk to health.
“The test 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 FDA said.
Moreover, “the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law.”
It is important to also note that on April 23, 2021, Innova Medical Group recalled their Innova SARS-CoV-2 Antigen Rapid Qualitative Test. (The FDA identified this recall as a Class I recall, the most serious type of recall.)
Health providers have been told, “If the test was given less than two weeks ago, consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.”