FDA Issues Safety Warnings About 3 COVID-19 Tests

The U.S. Food and Drug Administration (FDA) has issued three safety communications regarding COVID-19 tests that have been found to be in use but do not have FDA approval for distribution or use in the United States. The warnings were issued on March 1, 2022.

Celltrion USA Inc. DiaTrust™ COVID-19 Ag Rapid Tests:

The FDA is warning people not to use certain Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests, a product of Celltrion Healthcare.

The tests have green and white packaging.

This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results from this unauthorized test.

The FDA has not received reports of injuries, adverse health consequences, or deaths associated with use of the unauthorized test.

SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test:

The FDA is warning against using the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test.

The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States.

The FDA is concerned about the risk of false results from this unauthorized test, which may be packaged in a white and magenta box.

The FDA has not received reports of injuries, adverse health consequences, or deaths associated with use of the unauthorized test.

ACON Laboratories Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing):

The FDA is warning against the use of certain ACON Laboratories COVID-19 tests, a product of ACON Biotech (Hangzhou) Co., Ltd. Specifically, the FDA says people should not use the ACON Laboratories test named “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” that is packaged in a dark blue box.

This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results from this unauthorized test.  

The FDA has not received reports of injuries, adverse health consequences, or deaths associated with use of the unauthorized test. 

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Frequently Asked Question

How do I apply for a Clinical Laboratory Improvement Amendments (CLIA) certificate so that my facility can perform SARS-CoV-2 testing?

The federal CLIA program contracts with states to carry out certain oversight and recording functions of the CLIA program. The state in which the laboratory is located processes applications for CLIA certificates. After the laboratory has identified a qualified and certified laboratory director and has provided all required information on the Centers for Medicare & Medicaid Services’ CMS-116 application form, a CLIA number will be assigned. The laboratory can begin testing if applicable CLIA requirements have been met.

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