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    ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKP·July 1, 2021

    Diagnostic Kit SARS-cCo V Antigen Rapid Test

    FDA Recall
    Open, Classified ·USA Medical, LLC·Product code QKP·April 4, 2022

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Recall
    Terminated ·CELLTRION USA INC·Product code QKP·April 1, 2022

    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

    FDA Recall
    Open, Classified ·Acon Biotech (Hangzhou) Co., Ltd.·Product code QKP·January 9, 2022

    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

    FDA Recall
    Open, Classified ·CELLTRION USA INC·Product code QKP·February 25, 2022

    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test

    FDA Recall
    Open, Classified ·Migo Trading LLC·Product code QKP·November 4, 2021

    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).

    FDA Recall
    Completed ·LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Building 7-1 NO. 37 Chaoqian Rd; Changping Tech Zone Beijing China·Product code QKP·April 26, 2021

    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    FDA Recall
    Terminated ·Product code QKP·January 27, 2022

    Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.

    FDA Recall
    Terminated ·CELLTRION USA INC·Product code QKP·December 1, 2021

    Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"

    FDA Recall
    Open, Classified ·Cellex·Product code QKP·March 1, 2021

    ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code QKP·September 22, 2021

    Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    FDA Recall
    Open, Classified ·Woodside Acquisitions Inc.·Product code QKP·April 9, 2022

    Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

    FDA Recall
    Open, Classified ·LUMINOSTICS, INC dba CLIP HEALTH·Product code QKP·September 2, 2022

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code QKP·November 28, 2022

    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

    FDA Recall
    Open, Classified ·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·March 31, 2023

    VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. . For emergency authorization use only (EAU). Intended for Use in the United States Product Code: 6199949.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, Inc.·Product code QKP·February 12, 2021

    CovClear COVID-19 Rapid Antigen Test, ATG 900-031

    FDA Recall
    Completed ·Empowered Diagnostics LLC·Product code QKP·December 22, 2021

    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

    FDA Recall
    Open, Classified ·North American Diagnostics·Product code QKP·June 15, 2022

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·September 23, 2022

    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

    FDA Recall
    Open, Classified ·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025