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GenBody COVID-19 Ag

Genbody Inc. · Model COVAG025-NU · UDI-DI 08800076700482

QKP Prescription

510(k) clearances

26,765

Adverse events (5 deaths)

Recalls

Facilities

Description

Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.