GenBody COVID-19 Ag Home Test
Genbody Inc. · Model COVAGHT2-U-5 · UDI-DI 08800076700727
Description
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-24 | Guangzhou Pluslife Biotech Co., Ltd. | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |
| 2025-01-24 | Guangzhou Pluslife Biotech Co., Ltd. | Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA). |
| 2023-03-31 | SD Biosensor, Inc. | The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nos |
| 2022-12-08 | Detect Headquarters | There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of support |
| 2022-11-28 | Universal Meditech Inc. | Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization. |
| 2022-09-23 | LumiraDx | Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 |
| 2022-09-02 | LUMINOSTICS, INC dba CLIP HEALTH | COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence. |
| 2022-08-09 | Jiangsu Well Biotech Co.,Ltd. | Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance. |
| 2022-06-15 | North American Diagnostics | Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorizati |
| 2022-04-09 | Woodside Acquisitions Inc. | Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States. |
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