Reagent, Coronavirus Serological

FDA product code QKO · Not classified · Microbiology

The qualitative detection of IgM and/or IgG antibodies to coronavirus from human specimens.

0510(k) clearances
0PMA approvals
31recalls

Recalls

RecallProductFirmInitiated
Z-0059-2024 Class IIDiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS… Universal Meditech Inc.05/22/2023Open, Classified
Z-1396-2023 Class IIVITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed…Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2… Ortho-Clinical Diagnostics, Inc.03/09/2023Open, Classified
Z-1451-2022 Class IILumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality ControlModification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved… LumiraDx06/24/2022Terminated
Z-1450-2022 Class IILumiraDx SARS-CoV-2 Antibody (Ab) Test StripModification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved… LumiraDx06/24/2022Terminated
Z-1367-2022 Class IIAnti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600…On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the… Ortho-Clinical Diagnostics, Inc.05/26/2022Open, Classified
Z-1058-2022 Class IIProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood…FDA review concluded that the test is insufficiently supported by clinical performance data, and results… Proterixbio04/17/2022Terminated
Z-0718-2022 Class ICOVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog…COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or… Lusys Laboratories, Inc.01/13/2022Open, Classified
Z-0481-2022 Class IImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60COVID test kits were offered for sale and distributed to consumers in the United States without marketing… Empowered Diagnostics LLC12/22/2021Completed
Z-0439-2022 Class IIVIDAS SARS-COV-2 IgG, Ref 423834-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… bioMerieux, Inc.09/22/2021Open, Classified
Z-0438-2022 Class IIVIDAS SARS-COV-2 IgM, Ref 423833-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… bioMerieux, Inc.09/22/2021Open, Classified
Z-0120-2022 Class IIVITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For…VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control… Ortho Clinical Diagnostics Inc09/10/2021Terminated
Z-2508-2021 Class IIAccess SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF…Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA… Beckman Coulter Inc.08/05/2021Terminated
Z-2409-2021 Class IIHealgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative…Products may have been distributed to customers other than laboratories certified under the Clinical… Versea Diagnostics LLC07/27/2021Terminated
Z-2408-2021 Class IIFaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of…Products may have been distributed to customers other than laboratories certified under the Clinical… Versea Diagnostics LLC07/27/2021Terminated
Z-1906-2021 Class IIAccess SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running… Beckman Coulter Inc.05/07/2021Terminated
Z-1905-2021 Class IIAccess SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running… Beckman Coulter Inc.05/07/2021Terminated
Z-1619-2021 Class ILeccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1…Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized… Lepu Medical Technology (Beijing) Co., Ltd04/26/2021Completed
Z-1432-2021 Class IIAssure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid…Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month… Azure Biotech Inc03/02/2021Terminated
Z-1126-2021 Class IIOrient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF…Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use… Confirm Biosciences Inc01/29/2021Terminated
Z-1125-2021 Class IIHealgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a -…Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use… Confirm Biosciences Inc01/29/2021Terminated
Z-1127-2021 Class IIAntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit…Distributed COVID test kits without emergency use authorization. Sky Medical Supplies and Equipments LLC01/19/2021Terminated
Z-0875-2021 Class IIACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access…The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the… Beckman Coulter Inc.12/30/2020Terminated
Z-0842-2021 Class IIAnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1…Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune… Ansh Labs, LLC12/18/2020Terminated
Z-2382-2021 Class IIEL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128The cross-reactivity of the device may present an increased level of potential false positives. Submitted as… Thera Test Laboratories, Inc.10/05/2020Terminated
Z-0426-2021 Class IIEDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is…The use of deionized water rather than distilled water during the manufacturing process, may have resulted… Epitope Diagnostics, Inc.10/01/2020Open, Classified
Z-2381-2021 Class IIEL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately… Thera Test Laboratories, Inc.07/30/2020Terminated
Z-2771-2020 Class IIVITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919…The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or… Ortho Clinical Diagnostics07/17/2020Terminated
Z-2770-2020 Class IIVITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI…The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or… Ortho Clinical Diagnostics07/17/2020Terminated
Z-2809-2020 Class IIChembio DPP Micro Reader II for use with the DPP COVID-19 IgM/IgG System- Rapid…FDA revocation of the Emergency Use Authorization due to performance issues Chembio Diagnostics, Inc06/18/2020Terminated
Z-2808-2020 Class IIChembio DPP Micro Reader for use with the DPP COVID-19 IgM/IgG System- Rapid…FDA revocation of the Emergency Use Authorization due to performance issues Chembio Diagnostics, Inc06/18/2020Terminated
Z-2807-2020 Class IIChembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the…FDA revocation of the Emergency Use Authorization due to performance issues Chembio Diagnostics, Inc06/18/2020Terminated