Agency stresses the test is not authorized or approved by the FDA

Due to significant concerns about the lack of adequately established testing performance, the FDA issued a Class I recall of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test and warned the public, health care providers, and testing program organizers to stop using the test to diagnose Covid-19.

The test is comprised of a nasal swab sample and test strip designed to detect SARS-CoV-2 virus antigens.

In addition, says the FDA, certain labeling configurations included with the test cite claims about its performance that are not accurate reflections of performance estimates seen during clinical trials.

And finally, the FDA stressed, “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.”

In what the FDA classified as a Class I recall, Innova Medical Group recalled their test on April 23, 2021, which was also distributed under the following names:

  • Innova COVID-19 Self-Test Kit (3T Configuration).
  • Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration).
  • Innova SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration).

Recommendations call for the tests to be destroyed or returned to Innova with the FedEx return label included with recall letters sent by Innova to customers. Test users and caregivers are urged to reach out to their healthcare providers with any concerns about their results. Healthcare providers who suspect inaccurate results are urged to retest patients using a different SARS-CoV-2 diagnostic test in patients tested less than two weeks ago. Testing program organizers are urged to notify program participants to discontinue the use of the Innova test and replace it with other tests that are authorized by the FDA. Any problems should be reported to the FDA.

False-negative and false-positive results may “lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause the patient harm including serious illness and death.” And, in both cases, further spreading of the virus may result.

To date, there have been no reports or death or injuries linked to the use of Innova’s SARS-CoV-2 Antigen Rapid Qualitative Test.

The FDA has issued a warning letter to Innova Medical Group, Inc., and encourages anyone who thinks they have had a problem with the Innova SARS-CoV-2 Antigen Rapid Qualitative Test to report the problem through the MedWatch Voluntary Reporting Form. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

Liz Meszaros, Deputy Managing Editor, BreakingMED™

Cat ID: 125

Topic ID: 79,125,730,933,125,190,520,926,192,927,151,725,928,925,934