68 results
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Sources: EU EUDAMED, US FDA
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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
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
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
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
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
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
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
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
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Terminated
·CELLTRION USA INC·Product code QKP·December 2, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
FDA Recall
Terminated
·LumiraDx·Product code QKP·January 11, 2021
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories)
FDA Recall
Terminated
·Versea Diagnostics LLC·Product code QKP·July 27, 2021
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code QKP·September 22, 2021
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·April 14, 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
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Recall
Terminated
·CELLTRION USA INC·Product code QKP·December 28, 2021
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·July 1, 2021
SARS-CoV-2 Antigen Test
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code QKP·January 15, 2021