North American Diagnostics has recalled over 122,000 oral rapid COVID-19 antigen test kits because the products were distributed to customers in the U.S. without authorization, clearance or approval from the Food and Drug Administration.
The FDA labeled the recall a Class I event. The agency wrote that the products have the possibility of false positive or negative test results, misinterpretation of results and serious adverse health consequences, including death. According to the FDA’s Monday notice, there have been no reports of injuries or death associated with the recall.
“North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate,” the agency wrote.
The product is known as the Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit, and may also be called Oral Rapid Test or Oral Rapid Antigen Test, Lateral Flow COVID 19 Rapid Antigen Test, Skippack Medical Lab rapid antigen tests, Skippack COVID-19 Antigen Home Test, SML LDT Kits and other SML brand kits.
The recall affects 122,175 devices distributed between March 1, 2021, and Feb. 15, 2022.
North American Diagnostics sent an email to customers and distributors on June 15 asking for any existing devices to be quarantined and immediately destroyed.