SD Biosensor Recalls Unauthorized STANDARD Q COVID-19 Tests

U.S. Food and Drug Administration sent this bulletin at 03/16/2022 12:10 PM EDT

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CDRH Medical Device Recall

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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

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.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

This recall does not apply to the SD Biosensor COVID-19 At-Home Test, which was authorized by the FDA on December 24, 2021. 

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Questions?

If you have questions about this recall, contact 1-714-202-5789 or email info@lkconsultinggroup.com.