Home › Device types › CFP
Radioimmunoassay, Immunoreactive Insulin
FDA product code CFP · Class 1 · Clinical Chemistry
58
Registered devices
106
Adverse events
8
Recalls
27
510(k) clearances
Devices with this code
Anti-Insulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAtellica IM IRI DIL — Siemens Healthcare Diagnostics Inc.Anti-Insulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungADVIA Centaur® IRI — Siemens Healthcare Diagnostics Inc.INS ELISA — Diasource Immunoassays S.A. SAInsulin ELISA Kit (DAKO) — Mercodia ABMercodia Insulin ELISA 10 pack — Mercodia ABALPCO Ultrasensitive Insulin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.AIA-100 — Diasource Immunoassays S.A. SAInsulin ELISA — DRG International IncMonobind AccuBind Insulin Rapid ELISA Kit - 96 Wells — MONOBIND, INC.Mercodia Ultrasensitive Insulin ELISA — Mercodia ABInsulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungVITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — Abbott GmbHInsulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAIA-PACK IRI SAMPLE DILUTING SOLUTION — TOSOH CORPORATIONAtellica IM IRI — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHInsulin AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.Salimetrics — SALIMETRICS, LLCInsulin AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.AIA-PACK IRI CONTROL SET — TOSOH CORPORATIONIMMULITE® INS Control Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-07 | DRG International, Inc. | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or fi |
| 2023-11-21 | Beckman Coulter, Inc. | There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definitio |
| 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 |
| 2017-04-05 | Siemens Healthcare Diagnostics, Inc | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardiza |
| 2012-04-30 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
| 2012-04-30 | Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay. |
| 2007-09-19 | Beckman Coulter Inc | False negative results when used to test serum samples (as compared to plasma samples). |
| 2004-11-19 | Diagnostic Products Corp | Low bias of 10 to 40% at different levels of insulin in samples. |
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