North American Diagnostics is recalling oral-based SARS-CoV-2 rapid tests because they were distributed to U.S. customers without authorization, clearance, or approval from the U.S. FDA.

North American Diagnostics did not provide the FDA with adequate validation data to show that the test’s performance is accurate, the FDA says.This means there is a risk of potential false negative, false positive, or misinterpretation of results. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

There have been no complaints or reports of injuries or deaths. Roughly 122,175 of the devices have been recalled in the U.S.

The Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit uses patient samples collected by nasal swab to detect proteins, called antigens, found on the SARS-CoV-2 virus. These tests are intended to be used by clinical laboratories or health care workers for point-of-care testing.

Product names for the Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit may also be listed as:

  • 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)
    • SARS-CoV-2 Antigen Rapid Test Kit
  • SKIPPACK COVID-19 Antigen Home Test
  • SML LDT Kits
  • SML Brand:
    • Finished Kits
    • BT Test Kits
    • BT Antigen Test Kit LDT

On June 15, 2022, North American Diagnostics sent an Urgent Medical Device Recall email to customers, distributors, and other U.S. consignees requesting them to identify all affected product and quarantine to avoid use or distribution, and immediately destroy all unused product.