FDA (Devices) recall action 87682
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Due to distributing test kits to customers who were not part of a clinical investigation.
The agency’s own wording, quoted from the enforcement report.
Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.
INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.
Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.