Radioimmunoassay, Immunoreactive Insulin
Clinical Chemistry · 21 CFR 862.1405
Recent MDR events
102 adverse event reports on file
- ELECSYS INSULINJul 17, 2026MalfunctionRoche Diagnostics1823260-2026-02905
- ARCHITECT INSULINJun 11, 2026MalfunctionAbbott Gmbh3002809144-2026-00155
- ALINITY I INSULIN REAGENT KITJun 10, 2026MalfunctionAbbott Gmbh3002809144-2026-00153
- ALINITY I INSULIN REAGENT KITMay 20, 2026MalfunctionAbbott Gmbh3002809144-2026-00132
- ALINITY I INSULIN REAGENT KITApr 16, 2026MalfunctionAbbott Gmbh3002809144-2026-00094
- ELECSYS INSULINApr 3, 2026MalfunctionRoche Diagnostics1823260-2026-01233
- ELECSYS INSULINMar 25, 2026MalfunctionRoche Diagnostics1823260-2026-01083
- ARCHITECT INSULINMar 19, 2026MalfunctionAbbott Gmbh3002809144-2026-00065
- ALINITY I INSULIN REAGENT KITMar 4, 2026MalfunctionAbbott Gmbh3002809144-2026-00051
- ALINITY I INSULIN REAGENT KITJan 6, 2026MalfunctionAbbott Gmbh3002809144-2026-00003
Event type breakdown
Recalls
8 recall events for this product code
- DRG International, Inc.Open, ClassifiedJan 15, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
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 find controls out of specification (failed Control High) which causes a delay in results.
Z-0921-2025 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedFeb 5, 2024
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
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 definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of IU/mL to the International System of Units (SI units) of pmol/L.
Z-0981-2024 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedApr 19, 2017
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diagnostic use in the quantitative determination of insulin in s
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 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.
Z-2086-2017 · View FDA record ↗ - Siemens Healthcare DiagnosticsTerminatedJun 2, 2012
IMMULITE --- Insulin --- Catalog Number: LKIN1 (100 test), LKIN5 (500 tests) --- Test Code: INS, Color: Orange
Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
Z-1700-2012 · View FDA record ↗ - Siemens Healthcare DiagnosticsTerminatedJun 2, 2012
IMMULITE 2000 --- Insulin --- Catalog Number: L2KIN2 (200 test), L2KIN6 (600 tests) --- Test Code: INS, Color: Orange ---
Siemens Healthcare Diagnostics has observed a negative bias in the Immulite Insulin assay.
Z-1701-2012 · View FDA record ↗ - Beckman Coulter IncTerminatedJun 25, 2008
Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determina
False negative results when used to test serum samples (as compared to plasma samples).
Z-1160-2008 · View FDA record ↗ - Diagnostic Products CorpTerminatedDec 17, 2004
Immulite 2500 insulin Kit
Low bias of 10 to 40% at different levels of insulin in samples.
Z-0324-05 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK IRI; Part Number: 025260
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2076-2018 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Demeditec Diagnostics Gmbh
KIEL-WELLSEE Schleswig-Holstein, DE
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Diamond Diagnostics Inc.
Budapest, HU
Diasorin Deutschland Gmbh
Dietzenbach Hesse, DE
Beijing Hotgen Biotech Co., Ltd.
Beijing, CN
Immunocentrix Corporation
Canoga Park, CA, US
Kamiya Biomedical Company Llc
Tukwila, WA, US
Beckman Coulter, Inc.
CHASKA, MN, US
Shima Laboratories Co., Ltd.
ITABASHI-KU Tokyo, JP
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Tosoh Corp.
Chuo-ku Tokyo, JP
Drg International, Inc.
Springfield, NJ, US
Getein Biotech, Inc.
Nanjing Jiangsu, CN
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Tosoh Bioscience, Inc.
Grove City, OH, US
Denka Co., Ltd.
GOSEN-SHI Niigata, JP
Immuno-biological Laboratories, Inc.
Fridley, MN, US
Diasource Immunoassays, Sa
Louvain-La-Neuve Brabant Wallon, BE
Drg Instruments Gmbh
MARBURG Hesse, DE
Abbott Laboratories
Lake Forest, IL, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Boditech Med Inc.
Chuncheon Gangwon, KR
Eazebio
Livermore, CA, US
510(k) clearances
27 clearances for this product code
- American Laboratory Products Co., Ltd.Nov 1, 1996
K963911 · ALPCO/MERCODIA INSULIN ELISA
- Bio-Rad Laboratories, Inc.Sep 25, 1995
K953084 · ACCESS ULTRASENSITIVE INSULIN ASSAY
- Abbott LaboratoriesMay 7, 1992
K920109 · IMX INSULIN
- Diagnostic Systems Laboratories, Inc.Jan 9, 1992
K914820 · DSL INSULIN RIA (DSL 1600)
- Tosoh Corp.Sep 7, 1990
K903628 · AIA-PACK IRI
- Boehringer Mannheim Corp.Apr 3, 1990
K901135 · ENZYMUN TEST(R) INSULIN
- Helena LaboratoriesJan 11, 1990
K896572 · REP(TM) SPE PLUS-30 PROCEDURES
- Cambridge Medical TechnologyApr 26, 1989
K890837 · RIA-GNOST INSULIN