Coronavirus Antigen Detection Test System.
FDA product code QKP · Not classified · Microbiology
The qualitative detection of coronavirus viral antigens directly from clinical specimens.
0510(k) clearances
0PMA approvals
47recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1979-2025 Class II | Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card…Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization… | Guangzhou Pluslife Biotech Co., Ltd. | 01/24/2025Open, Classified |
| Z-1978-2025 Class II | Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog…Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization… | Guangzhou Pluslife Biotech Co., Ltd. | 01/24/2025Open, Classified |
| Z-1594-2023 Class I | Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number…The liquid buffer component in the affected test kit lots was determined to have bacterial contamination.… | SD Biosensor, Inc. | 03/31/2023Open, Classified |
| Z-0879-2023 Class II | Detect Covid-19 Test Product/Model Number: 21205There is an increased chance that the tests from affected lots may give false negative results. Health risks… | Detect Headquarters | 12/08/2022Open, Classified |
| Z-0929-2023 Class I | Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit…Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use… | Universal Meditech Inc. | 11/28/2022Open, Classified |
| Z-0135-2023 Class III | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002…Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were… | LumiraDx | 09/23/2022Terminated |
| Z-0080-2023 Class II | Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without… | LUMINOSTICS, INC dba CLIP HEALTH | 09/02/2022Open, Classified |
| Z-0001-2023 Class I | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a… | Jiangsu Well Biotech Co.,Ltd. | 08/09/2022Open, Classified |
| Z-1401-2022 Class I | SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test…Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in… | North American Diagnostics | 06/15/2022Open, Classified |
| Z-1045-2022 Class I | Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 TestFirm distributed tests which have not been cleared or authorized for marketing or distribution in the United… | Woodside Acquisitions Inc. | 04/09/2022Open, Classified |
| Z-1044-2022 Class I | Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 TestFirm distributed tests which have not been cleared or authorized for marketing or distribution in the United… | Woodside Acquisitions Inc. | 04/09/2022Open, Classified |
| Z-1050-2022 Class II | Diagnostic Kit SARS-cCo V Antigen Rapid TestCOVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests… | USA Medical, LLC | 04/04/2022Open, Classified |
| Z-0953-2022 Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. | Celltrion USA Inc | 04/01/2022Terminated |
| Z-0944-2022 Class I | Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 TestThe product was distributed without FDA authorization or clearance for marketing and distribution in the US. | SML Distribution, LLC | 03/04/2022Open, Classified |
| Z-0892-2022 Class II | First SIGN SARS-CoV-2 Antigen TestFrm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold… | WHPM Inc. | 03/04/2022Terminated |
| Z-0731-2022 Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Kits were labeled with incorrect expiration dates. | Celltrion USA Inc | 02/25/2022Open, Classified |
| Z-0719-2022 Class I | STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid…Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or… | SD Biosensor, Inc. | 01/31/2022Open, Classified |
| Z-0564-2022 Class I | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART KitThe Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It… | E25Bio, Inc. | 01/27/2022Terminated |
| Z-0717-2022 Class I | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant…COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or… | Lusys Laboratories, Inc. | 01/13/2022Open, Classified |
| Z-0716-2022 Class I | LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat:…COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or… | Lusys Laboratories, Inc. | 01/13/2022Open, Classified |
| Z-0945-2022 Class II | Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE markedNon-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market… | Acon Biotech (Hangzhou) Co., Ltd. | 01/09/2022Open, Classified |
| Z-0659-2022 Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives… | Celltrion USA Inc | 12/28/2021Terminated |
| Z-0480-2022 Class I | CovClear COVID-19 Rapid Antigen Test, ATG 900-031COVID test kits were offered for sale and distributed to consumers in the United States without marketing… | Empowered Diagnostics LLC | 12/22/2021Completed |
| Z-0680-2022 Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO).… | Celltrion USA Inc | 12/02/2021Terminated |
| Z-0558-2022 Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable…The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but… | Celltrion USA Inc | 12/01/2021Terminated |
| Z-0421-2022 Class II | FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 TestDevices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product… | Migo Trading LLC | 11/04/2021Open, Classified |
| Z-0183-2022 Class I | Ellume COVID-19 Home TestDue to a higher rate of false positive test results. | Ellume Ltd | 10/01/2021Open, Classified |
| Z-0196-2022 Class II | ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the… | Siemens Healthcare Diagnostics, Inc | 09/22/2021Terminated |
| Z-0195-2022 Class II | Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the… | Siemens Healthcare Diagnostics, Inc | 09/22/2021Terminated |
| Z-2407-2021 Class II | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen…Products may have been distributed to customers other than laboratories certified under the Clinical… | Versea Diagnostics LLC | 07/27/2021Terminated |
| Z-2258-2021 Class II | ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN…SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | Beckman Coulter Inc. | 07/01/2021Terminated |
| Z-2257-2021 Class II | ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1…SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | Beckman Coulter Inc. | 07/01/2021Terminated |
| Z-2256-2021 Class II | Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0…SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | Beckman Coulter Inc. | 07/01/2021Terminated |
| Z-2255-2021 Class II | ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . | Beckman Coulter Inc. | 07/01/2021Terminated |
| Z-1688-2021 Class II | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent…Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes… | Ortho-Clinical Diagnostics, INc. | 05/03/2021Terminated |
| Z-1620-2021 Class I | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1…Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S. | Lepu Medical Technology (Beijing) Co., Ltd | 04/26/2021Completed |
| Z-1670-2021 Class II | Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70…specimens collected in transport media may result is false negative results when stored in certain conditions. | Beckman Coulter Inc. | 04/14/2021Terminated |
| Z-1539-2021 Class I | COVID-19 Self-Test Kit *** INNOVA *** 3TDue to distributing test kits to customers who were not part of a clinical investigation. | Innova Medical Group, Inc. | 04/09/2021Open, Classified |
| Z-1538-2021 Class I | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen…Due to distributing test kits to customers who were not part of a clinical investigation. | Innova Medical Group, Inc. | 04/09/2021Open, Classified |
| Z-1537-2021 Class I | COVID-19 Self-Test Kit *** INNOVA *** 7TDue to distributing test kits to customers who were not part of a clinical investigation. | Innova Medical Group, Inc. | 04/09/2021Open, Classified |
| Z-2452-2021 Class II | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to…The kit does not have an emergency use authorization (EUA). | Cellex | 03/01/2021Open, Classified |
| Z-1267-2021 Class II | VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2…VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT… | Ortho-Clinical Diagnostics, Inc. | 02/12/2021Terminated |
| Z-1266-2021 Class II | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The…VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT… | Ortho-Clinical Diagnostics, Inc. | 02/12/2021Terminated |
| Z-1312-2021 Class II | Coronavirus antigen detection test system - Product Usage: intended for the qualitative…Two lots of test strips failed QC testing using blank buffer due to false positives. | LumiraDx | 02/03/2021Terminated |
| Z-0941-2021 Class II | SARS-CoV-2 Antigen TestQIAGEN has become aware of the potential for false positive results to occur with some patient samples. | Qiagen Sciences LLC | 01/15/2021Terminated |
| Z-1132-2021 Class II | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute…Observations of potential false positive results in the specified lots. Use of these test strips may result… | LumiraDx | 01/11/2021Terminated |
| Z-0124-2021 Class II | Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow…Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references… | Quidel Corporation | 09/17/2020Terminated |