Over-The-Counter Covid-19 Antigen Test
FDA adverse event reports and recall history for over-the-counter covid-19 antigen test (product code QYT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 139
- Deaths
- 0
- Injuries
- 3
- Malfunctions
- 136
Reports per year
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-09-27Open, ClassifiedUnknown/Undetermined by firm
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
- 2024-09-27Open, ClassifiedUnknown/Undetermined by firm
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
- 2024-09-27Open, ClassifiedUnknown/Undetermined by firm
DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
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