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    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199966

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code QKO·September 10, 2021

    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

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 20, 2021

    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

    VITROS SARS-CoV-2 Antigen Reagent Pack - 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). Product Code: 6199941. OUS Product.

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

    BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code QJR·January 7, 2021

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code QJR·September 2, 2021

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code QJR·September 2, 2021

    Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code QJR·September 2, 2021

    Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

    FDA Recall
    Terminated ·Quidel Corporation·Product code QJR·April 27, 2021

    VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 2020

    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

    FDA Recall
    Terminated ·Ortho Clinical Diagnostics Inc·Product code QMN·September 30, 2020

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·August 5, 2021

    VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, INc.·Product code QKP·May 3, 2021

    cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code QLT·August 4, 2021

    SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code OHQ·August 20, 2021

    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code QJR·September 2, 2021

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code QJR·September 2, 2021

    Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008

    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 23, 2020