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Need this for another post I’m working on.

FDA Recalls of Rapid Antigen Tests

• Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication
  • https://www.fda.gov/medical-devices/safety-communications/do-not-use-e25bio-covid-19-tests-fda-safety-communication
  • Risk of injury when self-collecting nasopharyngeal or oropharyngeal samples. Only trained health care providers should collect nasopharyngeal or oropharyngeal swab samples. People who were instructed to collect their own nasopharyngeal or oropharyngeal swab samples are at risk of serious injury including:
    • Pieces of the swab breaking off, as they may be more fragile and are not designed for throat swabbing, nasopharyngeal swabbing, or self-collection
  • The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall. 

• Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communicationhttps://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication
• The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.
• The liquid solution provided in the affected Pilot COVID-19 At-Home Test kits has been found to be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species.
  • Who: SD Biosensor recalled its Pilot COVID-19 At-Home Tests. 
  • Why: The company found potentially harmful bacteria inside the tube containing liquid.
  • Where: The SD Biosensor recall is active in the United States.
  • https://topclassactions.com/lawsuit-settlements/consumer-products/recalls/sd-biosensor-announces-pilot-covid-19-at-home-tests-recall-due-to-bacterial-contamination/

• Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
  • The FDA has classified the recall of the Ellume COVID-19 Home Test as a Class I recall, the most serious type of recall. Ellume has identified additional affected lots since our last update on October 5, 2021, and the total of affected tests is now around 2 million.
  • https://www.fda.gov/medical-devices/safety-communications/potential-false-positive-results-certain-lots-ellume-covid-19-home-tests-due-manufacturing-issue-fda
  • Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
  • https://www.fda.gov/medical-devices/medical-device-recalls/ellume-recalls-covid-19-home-test-potential-false-positive-sars-cov-2-test-results
• Stop Using Empowered Diagnostics COVID-19 Tests: FDA Safety Communication
  • The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. 
  • https://www.fda.gov/medical-devices/safety-communications/stop-using-empowered-diagnostics-covid-19-tests-fda-safety-communication
  • The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall. 
• Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
  • https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication
  • Curative SARS-Cov-2 Assay – KorvaLabs Inc.
  • https://www.fda.gov/media/137087/download
• Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
  • The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall.
  • https://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication
  • LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA
  • https://www.fda.gov/medical-devices/medical-device-recalls/lusys-laboratories-inc-recalls-covid-19-antigen-tests-nasalsaliva-and-covid-19-iggigm-antibody-tests
• Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication
  • https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-acon-flowflex-covid-19-tests-fda-safety-communication
• Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication
  • https://www.fda.gov/medical-devices/safety-communications/do-not-use-sd-biosensor-standard-q-covid-19-ag-home-tests-fda-safety-communication
  • SD Biosensor, Inc. has initiated a recall for all unauthorized SD Biosensor STANDARD Q COVID-19 Ag Home Tests that were distributed in the U.S.. The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall.
• Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
  • https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-celltrion-diatrust-covid-19-tests-fda-safety-communication
  • Class 2 Device Recall Celltrion DiaTrust COVID19 Ag Rapid Test
  • https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=191625
• Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication
  • https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety

….and hundreds more:

FDA Removed the list of names in 2021, but I found what the Rapid Antigen Test recall list was back on June 23, 2021 Archive

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