NEW YORK – North American Diagnostics is recalling its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit because it was not appropriately authorized by the US Food and Drug Administration, the agency said on Monday.
The agency classified it as a Class I recall, the most serious type of recall. North American Diagnostics initiated the recall on June 15.
According to the FDA, the company did not provide the agency with adequate validation data to prove the test's performance is accurate, meaning there is a risk of false negative or false positive results. There have been no complaints or reports of injuries or deaths.
The test uses nasal swabs to detect SARS-CoV-2 and is intended for use by clinical laboratories or healthcare workers for point-of-care testing.
Customers and distributors were told by North American Diagnostics to destroy all unused products and, if tests were distributed to third parties, to perform a recall from all purchasers.
The test may also be called Oral Rapid Test or Oral Rapid Antigen Test, Lateral Flow COVID 19 Rapid Antigen Test, Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold), Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Skippack COVID-19 Antigen Home Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, or SML Brand BT Antigen Test Kit LDT.