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Radioimmunoassay, Immunoreactive Insulin
FDA product code CFP · Class 1 · Clinical Chemistry
58
Registered devices
102
Adverse events
8
Recalls
27
510(k) clearances
Devices with this code
ADVIA Centaur® IRI — Siemens Healthcare Diagnostics Inc.ST AIA-PACK IRI — TOSOH CORPORATIONALPCO Insulin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.Insulin AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSAIA-100 — Diasource Immunoassays S.A. SASTELLUX® Chemi Human Insulin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.INS ELISA — Diasource Immunoassays S.A. SAAIA-PACK IRI CALIBRATOR SET — TOSOH CORPORATIONAtellica IM IRI DIL — Siemens Healthcare Diagnostics Inc.Elecsys Insulin — Roche Diagnostics GmbHInsulin — DRG International IncALPCO Insulin ELISA Jumbo — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ARCHITECT — Abbott GmbHSTELLUX® Chemi Human Insulin ELISA Jumbo — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.K-ASSAY® Insulin Reagent (L) — KAMIYA BIOMEDICAL COMPANY, LLCAtellica IM IRI DIL — Siemens Healthcare Diagnostics Inc.AIA-PACK IRI CONTROL SET — TOSOH CORPORATIONAlinity — Abbott GmbHAtellica IM IRI — Siemens Healthcare Diagnostics Inc.Anti-Insulin ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungIMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDInsulin ELISA Kit (DAKO) — Mercodia ABMercodia Insulin ELISA 10 pack — Mercodia AB
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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