15 results
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31ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
FDA Recall
Terminated
·Quidel Corporation·Product code JHI·November 23, 2010
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
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.
FDA Recall
Open, Classified
·Quidel Corporation·Product code QMN·January 3, 2024
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
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
FDA Recall
Open, Classified
·Quidel Corporation·Product code GTY·April 6, 2026
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
FDA Recall
Open, Classified
·Quidel Corporation·Product code DBA·February 1, 2023
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
FDA Recall
Open, Classified
·Quidel Corporation·Product code GTY·June 17, 2025
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
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
FDA Recall
Open, Classified
·Quidel Corporation·Product code PFQ·March 5, 2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
FDA Recall
Open, Classified
·Quidel Corporation·Product code PFQ·March 5, 2024
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