On March 24, 2021, we initiated a voluntary recall of approximately 77,000 Innova SARS-CoV-2 Antigen Rapid Qualitative Tests that we distributed between November 2, 2020 and March 22, 2021 in the US, except those distributed to certain clinical study sites. The recall initiated was the result of a then ongoing FDA inspection of Innova operations in Southern California. FDA published the recall notice on June 10, 2021.
Although the Innova SARS-CoV-2 Antigen Rapid Qualitative Test had been authorized in other countries, the product was not authorized, cleared, or approved by the FDA for use in the United States.
The Innova team has worked diligently to complete the recall and spared no resources to address and correct FDA’s findings and concerns. As of October 22, 2021, the Innova recall team has removed the recalled product from the market. The Innova recall team officially submitted a request to FDA to close the recall on October 22, 2021.
If you have any questions about this recall, please contact us at firstname.lastname@example.org
“We are committed to delivering quality products and services to our customers that make a difference in improving the human condition. We have learned from this recall experience, and as a result, improved our quality control processes with additional resources. Our goal is to ensure we comply with regulatory requirements where we operate. I invite you to learn more about our commitment to quality here. – Daniel Elliott, CEO, Innova Medical Group