BEUDAMED
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    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·February 20, 2013

    QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842

    FDA Recall
    Terminated ·Quidel Corporation·Product code JHI·November 23, 2010

    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·March 1, 2017

    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    FDA Recall
    Terminated ·Quidel Corporation·Product code GNX·December 3, 2012

    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

    FDA Recall
    Terminated ·Quidel Corporation·Product code OCC·January 25, 2017

    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.

    FDA Recall
    Terminated ·Quidel Corporation·Product code PFQ·June 22, 2017

    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

    FDA Recall
    Terminated ·Quidel Corporation·Product code PSZ·December 15, 2017

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

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

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    FDA Recall
    Terminated ·Quidel Corporation·Product code QKP·September 17, 2020

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    FDA Recall
    Terminated ·Quidel Corporation·Product code PSZ·September 25, 2020

    Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider

    FDA Recall
    Terminated ·Quidel Corporation·Product code QJR·August 13, 2021

    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·April 4, 2018

    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·August 9, 2017

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·October 28, 2020

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

    FDA Enforcement
    Class I ·Terminated·Quidel Corporation·July 7, 2021

    Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·September 22, 2021

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·November 18, 2020