COVID-19 Antigen Test Recalls

Availability of accurate, easy-to-use at-home antigen testing kits are an important tool in reducing the spread of COVID-19. It’s also important to make sure the testing kits are FDA approved. Here are some resources you can use and share with your patients.

Review the FDA's list of approved antigen test kits.

The FDA has issued several recalls of rapid antigen tests in the last several months. The list below is provided as a service. Please note that recalls happen frequently and it is best to check the FDA medical device recall list regularly.

Recalled Rapid Antigen Tests:

Update: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (May 5, 2023)
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests - FDA Safety Communication (May 4, 2023)
Universal Meditech Inc Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA (February 8, 2023)
Voluntary Recall of Three Detect Covid-19 Test Lots (December 08, 2022)
Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA (October 13, 2022)
North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA (August 1, 2022)
Woodside Acquisitions oral rapid SARS-CoV-2 antigen rapid test kits and Joysbio SARS-CoV-2 antigen rapid test kits (colloidal gold) (May 16, 2022)
Skippack Medical Lab SARS-CoV-2 rapid antigen test (May 10, 2022)
Mesa Biotech Inc. Accula SARS-CoV-2 rapid antigen test (limited lots, April 6, 2022)
SD Biosensor Standard Q COVID-19 Ag home test (March 16, 2022)
Celltrion DiaTrust COVID-19 Ag rapid test (limited lots, March 22, 2022)
E25Bio COVID-19 direct antigen rapid test (February 18, 2022)
Empowered Diagnostics CovClear COVID-19 rapid antigen test and ImmunoPass COVID-19 neutralizing antibody rapid test (January 28, 2022)
LuSys Laboratories COVID-19 antigen tests saliva/nasal (January 22, 2022) – These products may also have been sold under Luscient Diagnostics, Vivera Pharmaceuticals or EagleDX
ACON Laboratories Flowflex COVID-19 antigen home test (January 9, 2022)
Ellume COVID-19 home test (limited lots, October 5, 2021)