North American Diagnostics Recalls Oral Rapid SARS

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.

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.

North American Diagnostics is recalling these tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. North American Diagnostics did not provide the FDA with adequate validation data to show that the test's performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results.

Use of these tests may cause serious adverse health consequences or death.

There have been no complaints or reports of injuries or deaths.

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 take the following actions:

Customers with questions about this recall should contact Elizabeth A. Lashinsky, Manager, at [email protected] or call 407-312-7104.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

08/01/2022