FDA MedWatch - STANDARD Q COVID-19 Ag Home Tests by SD Biosensor:

U.S. Food and Drug Administration sent this bulletin at 03/17/2022 03:28 PM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: STANDARD Q COVID-19 Ag Home Tests by SD Biosensor: Class I Recall - Because Tests Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: SD Biosensor 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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 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.

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.

RECOMMENDATIONS: On February 2, 2022, SD Biosensor 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.

Health professionals and consumers 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.

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