FDA Alert: Class 1 Recall of Unauthorized COVID-19 Tests

This is a reprint of an FDA Alert.

North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA

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.

Recalled Product

• Product Names: Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit, 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)
    • 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
• Product Codes: See Recall Database Entry
• Distribution Dates: March 1, 2021, to February 15, 2022
• Devices Recalled in the U.S.: 122,175
• Date Initiated by Firm: June 15, 2022

Device Use
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.

Reason for Recall
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.

Who May be Affected
Distributors of the Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit.
People who were tested for SARS-CoV-2 using the Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit.
Health care providers and other organizations who used the Oral Rapid SARS-CoV-2 Rapid Antigen Test Kit.

What to Do
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 Elizabeth Lashinsky, ealash52@gmail.com.

Contact Information
Customers with questions about this recall should contact Elizabeth A. Lashinsky, Manager, at ealash52@gmail.com or call 407-312-7104.

Additional Resources
Medical Device Recall Database Entry
How do I report a problem?
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.