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

This is a reprint of an FDA Alert.

SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False 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.

Recalled Product

• Product Name: SD Biosensor STANDARD Q COVID-19 Ag Home Test
• Product Codes and Lot Numbers: See recall database entry
• Distribution Dates: August 26, 2021 to January 30, 2022
• Devices Recalled in the U.S.: Up to 397,700 units
• Date Initiated by Firm: January 31, 2022

Device Use

The SD Biosensor STANDARD Q COVID-19 Ag Home Test uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. This test is not authorized, cleared, or approved by the FDA for marketing or distribution in the United States.

Note: This recall does not apply to the SD Biosensor COVID-19 At-Home Test (also an antigen test), which was authorized by the FDA on December 24, 2021, and is distributed by Roche Diagnostics.

Reason for Recall

SD Biosensor Inc. is recalling its STANDARD Q COVID-19 Ag Home Tests because these tests were distributed to U.S. customers without authorization, clearance, or approval from the FDA.

As this test was not authorized, cleared, or approved by the FDA, there is not sufficient data demonstrating that the test's performance is accurate. This means there is a risk of both false-negative and false-positive test results. False negative results are when the test does not detect the SARS-CoV-2 virus but the person is actually infected. False-positive results occur when the test says the person has SARS-CoV-2 virus present, but they are not infected.

There have been no reports of injuries, adverse health consequences, or death associated with the use of the SD Biosensor STANDARD Q COVID-19 Ag Home Test.

Use of the affected product could cause serious adverse health consequences and death. On March 1, 2022, FDA issued a Safety Communication, Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests, warning users to stop using these tests.

Who May be Affected

• Distributors of the SD Biosensor STANDARD Q COVID-19 Ag Home Test
• Health care providers and other organizations who used the SD Biosensor STANDARD Q COVID-19 Ag Home Test to test patients for COVID-19.
• People who were tested for COVID-19 using the SD Biosensor STANDARD Q COVID-19 Ag Home Test.

What to Do

On February 2, 2022, SD Biosensor, Inc. issued a press release requesting U.S. distributors and customers take the following actions:

• Do not use the STANDARD Q COVID-19 Ag Home Test.
• Discard the test and avoid any use of the test.
• Consumers that have used the test are strongly encouraged to consider retesting with an FDA-authorized test.

The FDA's Safety Communication offered additional recommendations, including:

• Test users and caregivers: Talk to your health care provider if you think you were tested with the STANDARD Q COVID-19 Ag Home Test and you have concerns about your test results.
• Health care providers and testing program organizers: If an antigen test was performed less than two weeks ago using the STANDARD Q COVID-19 Ag Home Test, consider retesting your patients using an FDA-authorized or cleared SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
• Report any problems you experience with the STANDARD Q COVID-19 Ag Home Test to the FDA, including suspected false results. See Reporting Problems with Your Test.

In addition, to adequately address the serious public safety concern that these tests could be used in the near future, the FDA instructs all distributors in the United States in possession of these products to:

• Stop distributing and marketing these products. Contact SD Biosciences for assistance in removing these products from distribution or, alternatively, discard or destroy these products.

Contact Information

Customers with questions or concerns about this recall should contact 1-714-202-5789 or email:

info at lkconsultinggroup dot com.

Additional Resources

• Medical Device Recall Database Entry
• Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication

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.