FDA MedWatch - Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits by North American Diagnostics

Class I Recall - Tests Kits that Are Not Authorized, Cleared, or Approved by the FDA

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits: Class I Recall - Tests Kits that Are Not Authorized, Cleared, or Approved by the FDA AUDIENCE: Patient, Health Professional, Risk Manager, Laboratory ISSUE: North American Diagnostics is recalling these tests kits because they were distributed 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 kits may cause serious adverse health consequences or death. There have been no complaints or reports of injuries or deaths. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS: 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: Identify all affected product and quarantine to avoid use or distribution. Immediately destroy all unused product. If the tests were distributed to third parties, perform a recall from all purchasers. Complete a response form and return it to the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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