Home › Device types › LOJ
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA product code LOJ · Class 2 · Immunology
32
Registered devices
110
Adverse events
7
Recalls
17
510(k) clearances
Devices with this code
Monobind AccuLite AFP CLIA Kit - 192 Wells — MONOBIND, INC.Atellica IM Calibrator D — Siemens Healthcare Diagnostics Inc.AFP AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells — MONOBIND, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSElecsys AFP Assay — Roche Diagnostics GmbHAFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 Wells — MONOBIND, INC.Elecsys AFP — Roche Diagnostics GmbHAIA-PACK AFP Sample Diluting Solution — TOSOH CORPORATIONElecsys AFP Assay — Roche Diagnostics GmbHAFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 Wells — MONOBIND, INC.ST AIA-PACK AFP — TOSOH CORPORATIONMonobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 Wells — MONOBIND, INC.Elecsys AFP — Roche Diagnostics GmbHAFP AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Elecsys AFP — Roche Diagnostics GmbHAtellica IM Calibrator D — Siemens Healthcare Diagnostics Inc.VITROS — ORTHO CLINICAL DIAGNOSTICSAFP AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Atellica IM Calibrator D — Siemens Healthcare Diagnostics Inc.AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 Wells — MONOBIND, INC.AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 Wells — MONOBIND, INC.AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 Wells — MONOBIND, INC.Elecsys AFP — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 2016-05-09 | ORTHO-CLINICAL DIAGNOSTICS | Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction s |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2009-02-20 | Abbott Laboratories | The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution prot |
| 2007-09-18 | Abbott Laboratories | The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. pr |
| 2005-07-18 | Beckman Coulter Inc | Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous r |
| 2003-03-04 | Abbott Laboratories HPD/ADD | The IMx AFP Calibrators may cause depressed values for the IMx AFP Low Control, and cause patient results to be 20% lower than actual values |
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