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# North American Diagnostics Recalls Covid Tests
- URL: https://www.fdaweb.com/north-american-diagnostics-recalls-covid-tests/
- Published: 2022-08-01T12:00:00.000Z
- Updated: 2026-09-14T17:54:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152411

North American Diagnostics has recalled (Class 1) its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without FDA authorization, clearance, or approval. “North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/north-american-diagnostics-recalls-oral-rapid-sars-cov-2-rapid-antigen-test-kits-are-not-authorized?ref=fdaweb.com) says, adding that this leads to the risk of potential false negative, false positive, or misinterpretation of results. The tests are intended to be used by clinical laboratories or health care workers for point-of-care testing.