The Food and Drug Administration (FDA) has issued several safety communications warning individuals to stop using certain COVID-19 tests as they have not been authorized, cleared or approved for distribution or use in the United States.

In the safety communication, the FDA noted that use of unauthorized tests may increase the risk of false results. Specific tests that have been flagged by the Agency include:

DiaTrust COVID-19 Ag Rapid Test by Celltrion USA Inc. 

  • Description: green and white packaging (see image below). 
  • The unauthorized test uses a mid-turbinate nasal swab to detect SARS-CoV-2.
  • Tests not affected by this safety communication: DiaTrust COVID-19 Ag Home Test for home use (authorized on October 21, 2021) and DiaTrust COVID-19 Ag Rapid Test for point-of-care use (authorized on September 1, 2021).

Standard Q COVID-19 Ag Home Test by SD Biosensor Inc. 

  • Description: may be packaged in a white and magenta box (see image below).
  • The unauthorized test uses a nasal swab sample to detect SARS-CoV-2.
  • The SD Biosensor COVID-19 At-Home Test, authorized on January 5, 2022, is not affected by this safety communication.

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) by ACON Laboratories.

  • Description: packaged in a dark blue box with lettering and symbols in the lower right corner of the box including the letters “CE” (see image below).
  • The unauthorized test uses a nasal swab sample to detect SARS-CoV-2.
  • The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized on October 4, 2021, is not affected by this safety communication.

Healthcare providers should consider retesting patients using an FDA authorized SARS-CoV-2 diagnostic test if the antigen test was given less than 2 weeks prior. To date, there have been no reports of injuries, adverse health consequences, or death associated with the use of these tests.

Issues related to SARS-CoV-2 testing should be reported to the FDA’s MedWatch Voluntary Reporting Form.

References

  1. Do not use certain Celltrion DiaTrust COVID-19 Tests: FDA safety communication. News release. US Food and Drug Administration. March 1, 2022. Accessed March 2, 2022. https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-celltrion-diatrust-covid-19-tests-fda-safety-communication
  2. Do not use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA safety communication. News release. US Food and Drug Administration. March 1, 2022. Accessed March 2, 2022. https://www.fda.gov/medical-devices/safety-communications/do-not-use-sd-biosensor-standard-q-covid-19-ag-home-tests-fda-safety-communication
  3. Do not use certain ACON Flowflex COVID-19 Tests: FDA safety communication. News release. US Food and Drug Administration. March 1, 2022. Accessed March 2, 2022. https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-acon-flowflex-covid-19-tests-fda-safety-communication