Class I recall issued on North American Diagnostics rapid COVID-19 test

North American Diagnostics recalled a series of oral COVID-19 rapid antigen test kits, the FDA said Aug. 1.

The tests are designated a Class I recall, which is used for devices that may cause serious injuries or death, the agency said. They were distributed to customers without FDA authorization.

North American Diagnostics failed to provide sufficient data showing the test is accurate, the agency said.

The company is requesting that customers and distributors identify and destroy any of the unused kits, the FDA said.


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